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FDA 510(k) Application Details - K143655
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K143655
Device Name
Mouthguard, Prescription
Applicant
SICAT GMBH & CO. KG
BRUNNENALLEE 6
BONN 53177 DE
Other 510(k) Applications for this Company
Contact
MANFRED BREUER
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
12/23/2014
Decision Date
10/02/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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