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FDA 510(k) Application Details - K211158
Device Classification Name
Mouthguard, Over-The-Counter
More FDA Info for this Device
510(K) Number
K211158
Device Name
Mouthguard, Over-The-Counter
Applicant
Boyd Research, Inc.
5820 Bali Way S
St. Pete Beach, FL 33706 US
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Contact
James Boyd
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
OBR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/19/2021
Decision Date
09/17/2021
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
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