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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 K910313
Device Name ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
Applicant
OTOTECH, LTD.
810 N. LILAC DRIVE SUITE 220
MINNEAPOLIS,  MN  55422
Applicant Contact BRUCE D BULLOCK
Correspondent
OTOTECH, LTD.
810 N. LILAC DRIVE SUITE 220
MINNEAPOLIS,  MN  55422
Correspondent Contact BRUCE D BULLOCK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/24/1991
Decision Date 03/18/1991
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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