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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headlight, Fiberoptic Focusing
510(k) Number K924198
Device Name MODIFIED SITE FIBER OPTIC MODULE
Applicant
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact BRUNT MILLER
Correspondent
Chiron Vision Corp.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact BRUNT MILLER
Regulation Number886.4335
Classification Product Code
FCT  
Date Received08/20/1992
Decision Date 11/23/1992
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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