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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 K884372
Device Name MADSEN IGO1500 INSERTION GAIN OPTIMIZER
Applicant
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Applicant Contact ZOILA SEERY
Correspondent
MADSEN ELECTRONICS (CANADA) LTD.
2370 SPEERS ROAD
P.O. BOX 535
OAKVILLE, ONTARIO,  CA L6J5B4
Correspondent Contact ZOILA SEERY
Regulation Number874.3310
Classification Product Code
ETW  
Date Received10/18/1988
Decision Date 02/13/1989
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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