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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 K933546
Device Name V-SIL
Applicant
Esschem, Inc.
P.O. Box 56
Essington,  PA  19029
Applicant Contact FRED ROSENBERG
Correspondent
Esschem, Inc.
P.O. Box 56
Essington,  PA  19029
Correspondent Contact FRED ROSENBERG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/22/1993
Decision Date 11/02/1993
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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