The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Traumarrest And Bleedarrest Hemostatic Particles And Foam.
| Device ID | K070211 |
| 510k Number | K070211 |
| Device Name: | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
| Contact | Keith Roberts |
| Correspondent | Keith Roberts HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-01-22 |
| Decision Date | 2007-04-05 |
| Summary: | summary |