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FDA 510(k) Application Details - K053580
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K053580
Device Name
Mouthguard, Prescription
Applicant
DENTAL CONCEPTS LLC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MQC
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More FDA Info for this Product Code
Date Received
12/22/2005
Decision Date
03/03/2006
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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