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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 K853271
Device Name HEARING AID ANALYSIS SYSTEM
Applicant
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Applicant Contact CHERYL M LEISTER
Correspondent
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Correspondent Contact CHERYL M LEISTER
Regulation Number874.3310
Classification Product Code
ETW  
Date Received08/05/1985
Decision Date 01/16/1986
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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