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 |