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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 K950569
Device Name OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
Applicant
G.W.B. Intl., Ltd.
P.O. Box 465
Marshfield,  MA  02051
Applicant Contact ANNE BOHSACK
Correspondent
G.W.B. Intl., Ltd.
P.O. Box 465
Marshfield,  MA  02051
Correspondent Contact ANNE BOHSACK
Classification Product Code
LZU  
Date Received02/01/1995
Decision Date 03/14/1995
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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