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FDA 510(k) Application Details - K213406
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K213406
Device Name
Mask, Surgical
Applicant
Texas MedPlast LLC
6630 Roxburgh Drive #171
Houston, TX 77041 US
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Contact
Diego Olmos
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
10/19/2021
Decision Date
11/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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