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FDA 510(k) Application Details - K040315
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K040315
Device Name
Mouthguard, Prescription
Applicant
MCI-MYOHEALTH SYSTEMS
26552 TAMPICO PLACE
MISSION VIEJO, CA 92691 US
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DAVID BALDING
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
02/09/2004
Decision Date
08/27/2004
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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