The following data is part of a premarket notification filed by Core Scientific Creation Ltd. with the FDA for Woundclot9.
Device ID | K160679 |
510k Number | K160679 |
Device Name: | WoundClot9 |
Classification | Dressing, Wound, Drug |
Applicant | CORE SCIENTIFIC CREATION LTD. YOHANAN HASANDLAR 4 ST. POB 2270, 4464102 ISRAEL Kfar Saba, IL 4464102 |
Contact | Yuval Yaskil |
Correspondent | Sigalit Ariely-portnoy GSAP LTD. Pob 3, Shave-zion, IL 22806 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-10 |
Decision Date | 2016-08-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |