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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K972661
Device Name EYE SPHERE, CONFORMERS
Applicant
GULDEN OPHTHALMICS
225 CADWALADER AVE.
ELKINS PARK,  PA  19027 -2020
Applicant Contact THOMAS COCKLEY
Correspondent
GULDEN OPHTHALMICS
225 CADWALADER AVE.
ELKINS PARK,  PA  19027 -2020
Correspondent Contact THOMAS COCKLEY
Regulation Number886.3320
Classification Product Code
HPZ  
Subsequent Product Code
HQN  
Date Received07/16/1997
Decision Date 10/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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