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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 K780433
Device Name FIBER OPTIC ADJUSTABLE HEADLIGHT
Applicant
Cameron-Miller, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cameron-Miller, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4335
Classification Product Code
FCT  
Date Received03/17/1978
Decision Date 06/13/1978
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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