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FDA 510(k) Application Details - K091175
Device Classification Name
Mouthguard, Over-The-Counter
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510(K) Number
K091175
Device Name
Mouthguard, Over-The-Counter
Applicant
RANIR LLC
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
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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
04/22/2009
Decision Date
05/08/2009
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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