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FDA 510(k) Application Details - K212448
Device Classification Name
Mouthguard, Prescription
More FDA Info for this Device
510(K) Number
K212448
Device Name
Mouthguard, Prescription
Applicant
SprintRay Inc
2705 Media Center Drive, Suite 100A
Los Angeles, CA 90065 US
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Contact
Sara Moghtadernejad
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
08/05/2021
Decision Date
11/12/2021
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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