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FDA 510(k) Application Details - K200576
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K200576
Device Name
Mask, Surgical
Applicant
ClearMask, LLC
900 E. Fayette St., PO Box 22493
Baltimore, MD 21203 US
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Contact
Aaron Hsu
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
03/05/2020
Decision Date
04/06/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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