The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Excelarrest Foam.
| Device ID | K072900 |
| 510k Number | K072900 |
| Device Name: | EXCELARREST 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-11 |
| Decision Date | 2007-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858439001705 | K072900 | 000 |