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FDA 510(k) Application Details - K210636
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K210636
Device Name
Device, Anti-Snoring
Applicant
S4S UK Ltd.
151 Rutland Road
Sheffield S3 9PT GB
Other 510(k) Applications for this Company
Contact
Matthew Everatt
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
LRK
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More FDA Info for this Product Code
Date Received
02/19/2021
Decision Date
02/15/2022
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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