FDA 510(k) Application Details - K962292

Device Classification Name Protector, Hearing (Insert)

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510(K) Number K962292
Device Name Protector, Hearing (Insert)
Applicant EMTECH LABORATORIES
RT. 634 AT 760
HARDY, VA 24101 US
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Contact LOUISE H VERMILLIAN
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Regulation Number 000.0000

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Classification Product Code EWD
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Date Received 06/14/1996
Decision Date 10/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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