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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lacrimal stents and intubation sets
510(k) Number K911109
Device Name OPHTA SIL (R), LACHRYMAL INTUBATION SETS
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
Classification Product Code
OKS  
Date Received03/04/1991
Decision Date 05/01/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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