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FDA 510(k) Application Details - K111066
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K111066
Device Name
Mouthguard, Prescription
Applicant
MIGRATHERAPY LLC
4403 MANCHESTER AVENUE,
SUITE 103
ENCINITAS, CA 92024 US
Other 510(k) Applications for this Company
Contact
BRADLEY ELI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2011
Decision Date
11/22/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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