WOUNDCLOT HEMOSTATIC GAUZE

Dressing, Wound, Drug

CORE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Core Scientific Ltd. with the FDA for Woundclot Hemostatic Gauze.

Pre-market Notification Details

Device IDK140573
510k NumberK140573
Device Name:WOUNDCLOT HEMOSTATIC GAUZE
ClassificationDressing, Wound, Drug
Applicant CORE SCIENTIFIC LTD. POB 3 Shave-zion,  IL 22806
ContactSigalit Ariely-portnoy
CorrespondentSigalit Ariely-portnoy
CORE SCIENTIFIC LTD. POB 3 Shave-zion,  IL 22806
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-06
Decision Date2014-11-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290016339533 K140573 000
07290016339109 K140573 000
17290016339113 K140573 000
17290016339120 K140573 000
17290016339137 K140573 000
17290016339144 K140573 000
17290016339175 K140573 000
17290016339182 K140573 000
17290016339267 K140573 000
17290016339274 K140573 000
17290016339366 K140573 000
17290016339519 K140573 000
17290016339526 K140573 000
17290016339083 K140573 000

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