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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 K013613
Device Name SOFT PLUG ABSORBABLE PLUG-SA
Applicant
Oasis Medical, Inc.
514 S Vermont Ave.
Glendora,  CA  91741
Applicant Contact JAMES CHRISTENSEN
Correspondent
Oasis Medical, Inc.
514 S Vermont Ave.
Glendora,  CA  91741
Correspondent Contact JAMES CHRISTENSEN
Classification Product Code
LZU  
Date Received11/05/2001
Decision Date 06/27/2002
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
Recalls CDRH Recalls
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