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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, hearing aid / earphone and analysis systems
510(k) Number K902252
Device Name RASTRONICS CCI 10/3 HEARING AID ANALYSIS
Applicant
RASTRONICS USA, INC.
5407 W. 79TH ST.
P.O. BOX 78130
INDIANAPOLIS,  IN  46268 -8130
Applicant Contact ROBERT P WOLF
Correspondent
RASTRONICS USA, INC.
5407 W. 79TH ST.
P.O. BOX 78130
INDIANAPOLIS,  IN  46268 -8130
Correspondent Contact ROBERT P WOLF
Regulation Number874.3310
Classification Product Code
ETW  
Date Received05/21/1990
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
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