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 |