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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Light, Examination, Medical, Battery Powered
510(k) Number K760972
Device Name TYCOS DIAGNOSTIC PENLIGHT
Applicant
TAYLOR INSTRUMENT ANALYTICS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TAYLOR INSTRUMENT ANALYTICS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6350
Classification Product Code
KYT  
Date Received11/04/1976
Decision Date 01/26/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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