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FDA 510(k) Application Details - K133423
Device Classification Name
Mouthguard, Over-The-Counter
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510(K) Number
K133423
Device Name
Mouthguard, Over-The-Counter
Applicant
RANIR LLC
4701 EAST PARIS AVE. S.E.
GRAND RAPIDS, MI 49512 US
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Contact
PAULA BOJSEN
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Regulation Number
000.0000
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Classification Product Code
OBR
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More FDA Info for this Product Code
Date Received
11/08/2013
Decision Date
12/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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