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FDA 510(k) Application Details - K963591
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
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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More FDA Info for this Product Code
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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