The following data is part of a premarket notification filed by Core Scientific Ltd. with the FDA for Woundclot Hemostatic Gauze.
| Device ID | K140573 |
| 510k Number | K140573 |
| Device Name: | WOUNDCLOT HEMOSTATIC GAUZE |
| Classification | Dressing, Wound, Drug |
| Applicant | CORE SCIENTIFIC LTD. POB 3 Shave-zion, IL 22806 |
| Contact | Sigalit Ariely-portnoy |
| Correspondent | Sigalit Ariely-portnoy CORE SCIENTIFIC 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 | 2014-03-06 |
| Decision Date | 2014-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |