R-50 MANUFACTURED BY GULDEN OPHTHALMICS

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Request for Information Form	Contact Information
Company Name	GULDEN OPHTHALMICS
Address	225 CADWALADER AVE.
City, State, Zip	ELKINS PARK, PA 19027
Country	US
FDA Owner/Operator Phone	215-884-8105 201
FDA Medical Specialty Code	OP - Opthalmic
FDA Product Code	HLE
FDA Classification Name	RULER, NEARPOINT (PUNCTOMETER)
FDA Device Classification Code	General Controls
FDA Regulation Number	886.1790
FDA Common Generic Name	ACCOMMADATION RULE
FDA Proprietary Device Name	R-50
FDA Owner / Operator Number	2518410
FDA Owner / Operator Name	GULDEN OPHTHALMICS
FDA Establishment Registration Number	2518410
FDA Registered Establishment Name	GULDEN OPHTHALMICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-20-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ALBERT HEISS GMBH & CO. KG STOCKACHER STR. 138 TUTTLINGEN, 78532 GM 074-61-2527 / 074-612-527	RULER, NEARPOINT (PUNCTOMETER) OPHTHALMOLOGY	RULER
2	ALLGAIER INSTRUMENTE GMBH TEUCHELGRUBE 6-10 FRITTLINGEN, D-78665 GM 49-74-26 96 15-0 / 49-74-26 96 15-0	MULTIPLE	VARIOUS TYPES OF RULERS
3	CARTON OPTICAL INDUSTRIES, LTD. 27-11, HIGASHI UENO 1-CHOME, TAITO-KU TOKYO, 110-0015 JA 03-38-32-1320 / 410-793-0484	MULTIPLE	P.D.METER, RULER, UNIVERSAL SCALE
4	GEUDER AG HERTZSTRASSE 4 HEIDELBERG, D-69126 GM 490-62-213066 / 508-771-6777	GEUDER RULER	GEUDER RULER
5	HAAG STREIT UK LTD. EDINBURGH WAY HARLOW, ESSEX, CM20 2TT UK 41-31-9780100 / 44-127-9414969	RAF GAUGE	NEAR POINT RULE
6	INDO GERMAN SURGICAL CORP. 151 KALIANDAS UDYOG BHAVAN NEAR CENTURY BAZAR, PRABHADEVI BOMBAY, IN / 800-354-7848	RULER	RULER
7	LEONIDS TRADERS PVT. LTD. 36, LENIN SARANI CALCUTTA, IN / 800-354-7848	RULER	RULER
8	PAUL INSTRUMENTS (INDIA) 11/2 TAMER LN. CALCUTTA, IN / 800-354-7848	RULER	RULER
9	TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. SATTLERSTRASSE 11 NENDINGEN, TUTTLINGEN-16, D-78532 GM 004-974-61 1701 0 / 004-974-61 1701 0	NO PROPRIETARY NAME LISTED	SAME