KOH COLPOTOMIZER SYSTEM MANUFACTURED BY COOPERSURGICAL, INC.

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Request for Information Form	Contact Information
Company Name	COOPERSURGICAL, INC.
Address	95 CORPORATE DR.
City, State, Zip	TRUMBULL, CT 06611
Country	US
FDA Owner/Operator Phone	203-601-9825
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	HEW
FDA Classification Name	CULDOSCOPE (AND ACCESSORIES)
FDA Device Classification Code	General Controls
FDA Regulation Number	884.1640
FDA Common Generic Name	COLPO-PNEUMO OCCLUDER
FDA Proprietary Device Name	KOH COLPOTOMIZER SYSTEM
FDA Owner / Operator Number	9002384
FDA Owner / Operator Name	COOPERSURGICAL, INC.
FDA Establishment Registration Number	1216677
FDA Registered Establishment Name	COOPERSURGICAL, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-30-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900	MULTIPLE	CLAMP UMBILICAL
2	GYRUS ACMI, INC. 93 NORTH PLEASANT ST. NORWALK, OH 44857 US 011-44-189219750 / 508-804-2739	MULTIPLE	VARIOUS SIZES AND KINDS OF CULDOSCOPES AND ACCESSORIES
3	GYRUS ACMI, INC. 300 STILLWATER P.O.BOX 1971 STAMFORD, CT 06902 US 011-44-189219750 / 508-804-2739	MULTIPLE	VARIOUS SIZES AND KINDS OF CULDOSCOPES AND ACCESSORIES
4	KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. CHARLTON, MA 01507 US 49-74-617080 / 800-421-0837 4201	CULDOSCOPE	VARIOUS MODELS OF CULDOSCOPES
5	KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201	KARL STORZ CULDOSCOPE	VARIOUS MODELS OF CULDOSCOPES
6	SMITHS MEDICAL INTERNATIONAL LTD. BOUNDIRY RD. HYTHE, KENT, CT 21 5BN UK 114-420-8-458-3232 / 44-130-3260551	WALLACE FERTILOSCOPY KIT FH 1.29/FTO 1.40	INTRAUTERINE BALLOON CATHETER AND TRANSVAGINAL CANNULA