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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 K945255
Device Name MICROSIL
Applicant
Microsonic, Inc.
1421 Merchant St.
P.O. Box 184
Ambridge,  PA  15003
Applicant Contact MIKLOS MAJOR
Correspondent
Microsonic, Inc.
1421 Merchant St.
P.O. Box 184
Ambridge,  PA  15003
Correspondent Contact MIKLOS MAJOR
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/28/1994
Decision Date 11/29/1994
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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