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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 K870229
Device Name HEARING AID TEST SYSTEM MODEL HAT 1000
Applicant
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Applicant Contact GLEASON
Correspondent
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Correspondent Contact GLEASON
Regulation Number874.3310
Classification Product Code
ETW  
Date Received01/21/1987
Decision Date 03/13/1987
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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