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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 K853320
Device Name FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
Applicant
RASTRONICS USA, INC.
1125 GLOBE AVE.
MOUNTAINSIDE,  NJ  07092
Applicant Contact IRWIN KLAR
Correspondent
RASTRONICS USA, INC.
1125 GLOBE AVE.
MOUNTAINSIDE,  NJ  07092
Correspondent Contact IRWIN KLAR
Regulation Number874.3310
Classification Product Code
ETW  
Date Received07/30/1985
Decision Date 09/27/1985
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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