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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K903575
Device Name CHIROFLEX FORCEPS
Applicant
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact MCJARVEY
Correspondent
Chiron Ophthalmics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact MCJARVEY
Regulation Number886.4300
Classification Product Code
KYB  
Date Received08/08/1990
Decision Date 12/21/1990
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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