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FDA 510(k) Application Details - K200657
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K200657
Device Name
Device, Anti-Snoring
Applicant
SmartGuard Rx Inc.
2112 North Hill Field Rd. Suite 2A
Layton, UT 84041 US
Other 510(k) Applications for this Company
Contact
Brian Larsen
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
03/12/2020
Decision Date
08/23/2021
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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