FDA 510(k) Application Details - K963591

Device Classification Name Device, Anti-Snoring

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510(K) Number K963591
Device Name Device, Anti-Snoring
Applicant KENNETH HILSEN
12 EAST 41ST ST.
NEW YORK, NY 10017 US
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Contact STEPHEN E FELDMAN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 09/09/1996
Decision Date 01/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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