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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 K923227
Device Name THROAT-A-SCOPE
Applicant
Truphatek, Ltd.
P.O. Box 8051
Netanya,  IL 42106
Applicant Contact EMANUEL A ROSEN
Correspondent
Truphatek, Ltd.
P.O. Box 8051
Netanya,  IL 42106
Correspondent Contact EMANUEL A ROSEN
Regulation Number874.4350
Classification Product Code
EQH  
Date Received07/01/1992
Decision Date 12/04/1992
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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