FDA 510(k) Application Details - K961729

Device Classification Name Hearing Aid, Air Conduction

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510(K) Number K961729
Device Name Hearing Aid, Air Conduction
Applicant ARGOSY ELECTRONICS
10300 WEST 70TH ST.
P.O. BOX 59072
EDEN PRAIRIE, MN 55344 US
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Contact DENNIS J DAVIS
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Regulation Number 874.3300

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Classification Product Code ESD
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Date Received 05/03/1996
Decision Date 05/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
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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