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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K902784
Device Name FIBER OPTIC LIGHT SOURCE
Applicant
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number874.4350
Classification Product Code
EQH  
Date Received06/26/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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