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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 K980437
Device Name SILICONE PUNCTAL PLUG
Applicant
Oasis Medical, Inc.
514 S. Vermont Ave.
P.O. Box 1137
Glendora,  CA  91741
Applicant Contact NORMAN DELGADO
Correspondent
Oasis Medical, Inc.
514 S. Vermont Ave.
P.O. Box 1137
Glendora,  CA  91741
Correspondent Contact NORMAN DELGADO
Classification Product Code
LZU  
Date Received02/04/1998
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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