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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
Predetermined Change
Control Plan Authorized		 No
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