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FDA 510(k) Application Details - K111207
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K111207
Device Name
Device, Anti-Snoring
Applicant
RESPIRE MEDICAL
22817 VENTURA BLVD #161
WOODLAND HILLS, CA 91364 US
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Contact
DANIELA LEVY
Other 510(k) Applications for this Contact
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
04/29/2011
Decision Date
08/23/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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