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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K911108
Device Name OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
Applicant
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Applicant Contact GEORGE W BOHSACK
Correspondent
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Correspondent Contact GEORGE W BOHSACK
Classification Product Code
LZU  
Date Received03/04/1991
Decision Date 05/13/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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