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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 K915861
Device Name MEDILENS-CS CORNEAL SHIELD
Applicant
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact CAROL L PATTERSON
Correspondent
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact CAROL L PATTERSON
Regulation Number886.4750
Classification Product Code
MOE  
Date Received12/31/1991
Decision Date 03/06/1992
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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