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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 K802769
Device Name FIBER OPTIC HEADLIGHT #60-0765
Applicant
ASPEN LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ASPEN LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4335
Classification Product Code
FCT  
Date Received11/03/1980
Decision Date 12/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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