FIXATION STICKS 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	HPL
FDA Classification Name	DEVICE, FIXATION, AC-POWERED, OPHTHALMIC
FDA Device Classification Code	General Controls
FDA Regulation Number	886.1290
FDA Common Generic Name	FIXATION STICKS
FDA Proprietary Device Name	FIXATION STICKS
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	02-15-99
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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1	BILINK INTERNATIONAL, INC. 8329 LEFFERTS BLVD #1 KEW GARDENS, NY 11415 US 718-791-0732 / 718-791-0732	BILINK USA	FIXATION DEVICE
2	GLOBAL SURGICAL CORP. 3610 TREE CT. INDUSTRIAL BLVD. ST. LOUIS, MO 63122 US 314-861-3388 / 636-861-3388 5249	M824 MICROSCOPE FIXATION DEVICE FOR RETRACTIVE SURGERY	FIXATION DEVICE
3	HANSEN OPHTHALMIC DEVELOPMENT LAB 745 AVALON PL. CORALVILLE, IA 52241 US 319-338-1285 / 319-338-1285	SCOTT FIXATION DEVICE	A DISTANT FIXATION DEVICE FOR CHILDREN
4	OPHTHALMIC INTL. 16857 SAGUARO BLVD. FOUNTAIN HILLS, AZ 85268 US 480-837-6810 / 480-837-6810	OI FIX	FIXATION DEVICE
5	S.A. INSTRUMENTATION DIFRA RUE DE L'EGLISE 84 WELKENRAEDT, 4840 BE 32-87-898080 / 307-637-5711	VISIOSTAR, OPTILAS, VARIOUS OTHER MODELS	VARIOUS MODELS OF FIXATION DEVICES