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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
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