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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 K940508
Device Name OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
Applicant
G.W.B. Intl., Ltd.
18 Clark Ln.
Sudbury,  MA  01776
Applicant Contact GEORG W BOHSACK
Correspondent
G.W.B. Intl., Ltd.
18 Clark Ln.
Sudbury,  MA  01776
Correspondent Contact GEORG W BOHSACK
Classification Product Code
OKS  
Date Received02/04/1994
Decision Date 05/04/1994
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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