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FDA 510(k) Application Details - K172760
Device Classification Name
Device, Anti-Snoring
More FDA Info for this Device
510(K) Number
K172760
Device Name
Device, Anti-Snoring
Applicant
Insert Molding Solutions, Inc.
4325 Settingdown Circle, Suite 103
Cumming, GA 30028 US
Other 510(k) Applications for this Company
Contact
Paul Hendrixson
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
09/13/2017
Decision Date
03/26/2018
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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