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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 K001234
Device Name BIOINSULATED SILICONE PUNCTUM PLUG
Applicant
Advanced Vision Science
5743 Thornwood Dr.
Goleta,  CA  93117
Applicant Contact KHALID MENTAK
Correspondent
Advanced Vision Science
5743 Thornwood Dr.
Goleta,  CA  93117
Correspondent Contact KHALID MENTAK
Classification Product Code
LZU  
Date Received04/17/2000
Decision Date 07/11/2000
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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