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FDA 510(k) Application Details - K121285
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K121285
Device Name
Device, Anti-Snoring
Applicant
NEW JERSEY SNORING SOLUTIONS
769 NORTHFIELD AVENUE
SUITE 154
WEST ORANGE, NJ 07052 US
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Contact
DEBORAH STEIN
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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
04/30/2012
Decision Date
03/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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