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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 K842832
Device Name A.S.P.C./CLEARSOUND
Applicant
Asl, Inc.
4725 Excelsior Blvd
St. Louis Park,  MN  55416 -
Applicant Contact DAVID HILTON
Correspondent
Asl, Inc.
4725 Excelsior Blvd
St. Louis Park,  MN  55416 -
Correspondent Contact DAVID HILTON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/20/1984
Decision Date 11/09/1984
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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