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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collagen Corneal Shield
510(k) Number K913148
Device Name COLLAGEN SHIELD FOR ACUTE CARE
Applicant
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact JAN TOMSIC
Correspondent
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact JAN TOMSIC
Regulation Number886.4750
Classification Product Code
MOE  
Date Received07/16/1991
Decision Date 10/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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