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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 K962241
Device Name GORE SPHEREX IMPLANT
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Applicant Contact JOHN W NICHOLSON
Correspondent
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Correspondent Contact JOHN W NICHOLSON
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received06/11/1996
Decision Date 08/22/1996
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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