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FDA 510(k) Application Details - K223823
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K223823
Device Name
Mask, Surgical
Applicant
Efofex, Inc.
1300 North Dixieland Road
Rogers, AR 72756 US
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Contact
Siddhant Doshi
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FXX
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More FDA Info for this Product Code
Date Received
12/21/2022
Decision Date
03/27/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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