COOK CERVICAL BALLOON MANUFACTURED BY COOK UROLOGICAL, INC.

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COOK CERVICAL BALLOON

Request for Information Form	Contact Information
Company Name	COOK UROLOGICAL, INC.
Address	1100 WEST MORGAN ST.
City, State, Zip	SPENCER, IN 47460
Country	US
FDA Owner/Operator Phone	812-829-4891
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	HDY
FDA Classification Name	DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA
FDA Device Classification Code	Standards
FDA Regulation Number	884.4260
FDA Common Generic Name	CERVICAL RIPENING BALLOON
FDA Proprietary Device Name	COOK CERVICAL BALLOON
FDA Owner / Operator Number	1825146
FDA Owner / Operator Name	COOK UROLOGICAL, INC.
FDA Establishment Registration Number	1825146
FDA Registered Establishment Name	COOK UROLOGICAL, INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	02-23-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of COOK UROLOGICAL, INC.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	NO PROPRIETARY NAME LISTED	VARIOUS
2	CHESHIRE MEDICAL SPECIALTIES, INC. 1608 STURBRIDGE CT. P.O. BOX 894 CHESHIRE, CT 06410 US 203-272-1364 / 203-272-1364	DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA	DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA
3	COOPERSURGICAL, INC. 95 CORPORATE DR. TRUMBULL, CT 06611 US 203-601-9825 / 203-601-5200 9825	DILATERIA, LAMINARIA JAPONICA	LAMINARIA JAPONICA, VARIOUS SIZES
4	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	LAMINARIA TENTS	LAMINARIA TENTS
5	ERBRICH INSTRUMENTE GMBH EUGENSTRASSE 33 TUTTLINGEN, D-78532 GM 49-746-19657315 / 49-746-19657315	MULTIPLE	OBSTETRICAL FORCEPS
6	GREEN MEDIX CORP. 2-17-13 HONGO BUNKYO-KU, TOKYO, JA 03-381-2-2387 / 03-381-2-2387	LAMINARIA	LAMINARIA
7	KVALEBERG INDUSTRI A/S MIDTGARDVEIEN 2 STAVANGER, 4065 NO 47-515-24251 / 47-51-950495	STAOL SEA TANGLE TENT	LAMINARIA TENT
8	LUNEAU SAS 1 AVE. DE MALAGUET PRUNAY-LE-GILLON, 28360 FR 972-2-679 7401 / 33-237-252525	LAMINARIA	CERVICAL DILATOR
9	MEDGYN PRODUCTS, INC. 328 NORTH EISENHOWER LN. LOMBARD, IL 60148 US 630-627-4105 / 630-627-4105	MEDGYN LAMINARIA	LAMINARIA
10	MIZUTANI LAMINARIA, INC. 8-11 HIGASHISAKURA, 1-CHOME HIGASHI-KU, NAGOYA, 461 JA 052-951-5812 / 052-951-5812	MIZUTANI LAMINARIA TENT	LAMINARIA TENT
11	NORSCAN TRADING GROUP 2629 COUNTRY LANE WESTLAKE VILLAGE, CA 91361 US 818-735-0019 / 818-735-0019		CERVICAL DILATOR NATURAL
12	OLA OLSEN EFTF A.S. P.O. BOX 52 STAVANGER, N-4001 NO 818-735-0019 / 818-735-0019	LAMINARIA DIGITATA, STAOL LAMINARIA TENTS	LAMINARIA
13	OLAV GOKSOYR OG DATTER ANS RUNDE , 6096 RUNDE NO 47-515-24251 / 47-700-85965	STAOL SEA TANGLE TENT	LAMINARIA TENT
14	PANPAC MEDICAL CORPORATION NO. 202, 6F-1.2, SEC.3 TATONG ROAD SHI-CHIH CITY, TAIPEI HSIEN, TW 886-2-86472242 / 215-946-1954	LAMINARIA	LAMINARIA
15	RANDSEN CORP. 1800 WYATT DR., SUITE 3 SANTA CLARA, CA 95054 US 408-970-9397 / 408-970-9397		CERVICAL DIALATOR