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FDA 510(k) Application Details - K022627
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K022627
Device Name
Mouthguard, Prescription
Applicant
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
1801 K ST. NW
SUITE 1200
WASHINGTON, DC 20006 US
Other 510(k) Applications for this Company
Contact
G. BRENT CONNOR
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
08/07/2002
Decision Date
03/18/2003
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
FDA Source Information for K022627
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