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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 K914529
Device Name SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
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
Regulation Number886.4750
Classification Product Code
MOE  
Date Received10/11/1991
Decision Date 11/13/1991
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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