WoundClot9

Dressing, Wound, Drug

CORE SCIENTIFIC CREATION LTD.

The following data is part of a premarket notification filed by Core Scientific Creation Ltd. with the FDA for Woundclot9.

Pre-market Notification Details

Device IDK160679
510k NumberK160679
Device Name:WoundClot9
ClassificationDressing, Wound, Drug
Applicant CORE SCIENTIFIC CREATION LTD. YOHANAN HASANDLAR 4 ST. POB 2270, 4464102 ISRAEL Kfar Saba,  IL 4464102
ContactYuval Yaskil
CorrespondentSigalit Ariely-portnoy
GSAP 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 Received2016-03-10
Decision Date2016-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290016339410 K160679 000
07290016339871 K160679 000
07290016339888 K160679 000
07290016339895 K160679 000
17290016339908 K160679 000
17290016339304 K160679 000
07290016339376 K160679 000
17290016339380 K160679 000
17290016339397 K160679 000
17290016339403 K160679 000
07290016339864 K160679 000

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