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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K902205
Device Name OTOSCOPE
Applicant
TRUPHATEK, LTD.
P.O. BOX 8051
NETANYA,  IL 42106
Applicant Contact DAVID GREY
Correspondent
TRUPHATEK, LTD.
P.O. BOX 8051
NETANYA,  IL 42106
Correspondent Contact DAVID GREY
Regulation Number874.4770
Classification Product Code
ERA  
Date Received05/16/1990
Decision Date 08/14/1990
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
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