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FDA 510(k) Application Details - K152561
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K152561
Device Name
Mask, Surgical
Applicant
Prestige Ameritech, Ltd
7201 Iron Horse Blvd.
North Richland Hills, TX 76180 US
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Contact
Rex Reese
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
09/09/2015
Decision Date
06/03/2016
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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