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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 K902244
Device Name RASTRONICS CCI 8
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 Received05/18/1990
Decision Date 10/05/1990
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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