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FDA 510(k) Application Details - K190012
Device Classification Name
More FDA Info for this Device
510(K) Number
K190012
Device Name
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Applicant
Medtrade Product Ltd
Electra House, Electra way, Crewe Business Park
Crewe CW1 6GL GB
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Contact
Mina Patel
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2019
Decision Date
12/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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