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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name protector, hearing (insert)
510(k) Number K971517
Device Name SILICONE PUTTY EAR PLUGS
Applicant
BENTEC MEDICAL, INC.
4234 NORTH FREEWAY BLVD.
SACRAMENTO,  CA  95834
Applicant Contact LOUIS R MATSON
Correspondent
BENTEC MEDICAL, INC.
4234 NORTH FREEWAY BLVD.
SACRAMENTO,  CA  95834
Correspondent Contact LOUIS R MATSON
Classification Product Code
EWD  
Date Received04/25/1997
Decision Date 06/02/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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