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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 K911110
Device Name OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
Applicant
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Applicant Contact GEORG W BOHSACK
Correspondent
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Correspondent Contact GEORG W BOHSACK
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received03/04/1991
Decision Date 06/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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