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FDA 510(k) Application Details - K093340
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K093340
Device Name
Device, Anti-Snoring
Applicant
EXACT SUPPLIES LTD.
THE STABLES,BRIGHTWELL BALDWIN
WATLINGTON, OXFORDSHIRE OX49 5NP GB
Other 510(k) Applications for this Company
Contact
JONATHAN PARKINSON
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
LRK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/2009
Decision Date
06/11/2010
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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