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FDA 510(k) Application Details - K071404
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K071404
Device Name
Mouthguard, Prescription
Applicant
POWER PRODUCTS, INC.-SPLINTEK
9755 RIDGE DRIVE
LENEXA, KS 66219 US
Other 510(k) Applications for this Company
Contact
MALANIE HASEK
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
05/21/2007
Decision Date
08/17/2007
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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