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FDA 510(k) Application Details - K180933
Device Classification Name
Mouthguard, Over-The-Counter
More FDA Info for this Device
510(K) Number
K180933
Device Name
Mouthguard, Over-The-Counter
Applicant
Medtech Products Inc.
660 White Plains Rd
Suite 250
Tarrytown, NY 10591 US
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Contact
Mary Beth Fritz
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OBR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2018
Decision Date
09/17/2018
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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