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FDA 510(k) Application Details - K201095
Device Classification Name
Mask, Surgical
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510(K) Number
K201095
Device Name
Mask, Surgical
Applicant
HomTex, Inc.
2125 2nd Avenue SW
Cullman, AL 35055 US
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Contact
Jeremy Wootten
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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
04/24/2020
Decision Date
03/19/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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