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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 K955671
Device Name RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
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
OKS  
Date Received12/04/1995
Decision Date 03/06/1996
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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