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FDA 510(k) Application Details - K102521
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K102521
Device Name
Device, Anti-Snoring
Applicant
SOMNOMED INC.
3537 TEASLEY LANE
DENTON, TX 76210 US
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Contact
BRADLEY SOUTHWORTH
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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
09/02/2010
Decision Date
03/28/2011
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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