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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 K885016
Device Name COI 24 HR COLLAGEN SHIELD
Applicant
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact MCGARVEY
Correspondent
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact MCGARVEY
Regulation Number886.4750
Classification Product Code
MOE  
Date Received12/05/1988
Decision Date 02/01/1989
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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