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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K850189
Device Name BOSCH STAR 66PP-S HEARING AID
Applicant
ROBERT BOSCH CORP.
FLOWER FIELD BLDG. #17
MILL POND ROAD
ST. JAMES,  NY  11780
Applicant Contact CHERYL M LEISTER
Correspondent
ROBERT BOSCH CORP.
FLOWER FIELD BLDG. #17
MILL POND ROAD
ST. JAMES,  NY  11780
Correspondent Contact CHERYL M LEISTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/18/1985
Decision Date 03/25/1985
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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