QuikClot Control+

Temporary, Internal Use Hemostatic

Z-Medica, LLC

The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for Quikclot Control+.

Pre-market Notification Details

Device IDK200167
510k NumberK200167
Device Name:QuikClot Control+
ClassificationTemporary, Internal Use Hemostatic
Applicant Z-Medica, LLC 4 Fairfield Boulevard Wallingford,  CT  06492
ContactSoraya King
CorrespondentSoraya King
Z-Medica, LLC 4 Fairfield Boulevard Wallingford,  CT  06492
Product CodePOD  
CFR Regulation Number878.4454 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-23
Decision Date2020-04-23

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