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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 K944872
Device Name BIO-COR COLLAGEN CORNEAL SHIELD
Applicant
Bausch & Lomb Healthcare and Optics Worldwide
8500 Hidden River Pkwy.
Tampa,  FL  33637
Applicant Contact BRENDA MINNO
Correspondent
Bausch & Lomb Healthcare and Optics Worldwide
8500 Hidden River Pkwy.
Tampa,  FL  33637
Correspondent Contact BRENDA MINNO
Regulation Number886.4750
Classification Product Code
MOE  
Date Received10/03/1994
Decision Date 07/26/1995
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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