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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 K962292
Device Name HEARSAVER
Applicant
EMTECH LABORATORIES
RT. 634 AT 760
HARDY,  VA  24101
Applicant Contact LOUISE H VERMILLIAN
Correspondent
EMTECH LABORATORIES
RT. 634 AT 760
HARDY,  VA  24101
Correspondent Contact LOUISE H VERMILLIAN
Classification Product Code
EWD  
Date Received06/14/1996
Decision Date 10/29/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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