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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 K874225
Device Name BIO-COR EXT COLLAGEN CORNEAL SHIELD
Applicant
Bausch & Lomb, Inc.
11300 49th St., N.
Clearwater,  FL  34622
Applicant Contact MICHAEL STEVENS
Correspondent
Bausch & Lomb, Inc.
11300 49th St., N.
Clearwater,  FL  34622
Correspondent Contact MICHAEL STEVENS
Regulation Number886.4750
Classification Product Code
MOE  
Date Received10/16/1987
Decision Date 01/22/1988
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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