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FDA 510(k) Application Details - K200167
Device Classification Name
More FDA Info for this Device
510(K) Number
K200167
Device Name
QuikClot Control+
Applicant
Z-Medica, LLC
4 Fairfield Boulevard
Wallingford, CT 06492 US
Other 510(k) Applications for this Company
Contact
Soraya King
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
POD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/23/2020
Decision Date
04/23/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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