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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 Rd.
P.O. Box 535
Oakville, Ontario,  CA L6J5B4
Applicant Contact ZOILA SEERY
Correspondent
Madsen Electronics (Canada) , Ltd.
2370 Speers Rd.
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
Predetermined Change
Control Plan Authorized		 No
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