The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Nosebleed.
| Device ID | K080247 |
| 510k Number | K080247 |
| Device Name: | QUIKCLOT NOSEBLEED |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Ronald E Peterson |
| Correspondent | Ronald E Peterson Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| 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 | 2008-01-31 |
| Decision Date | 2008-02-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUIKCLOT NOSEBLEED 77570786 3745266 Dead/Cancelled |
Z-MEDICA, LLC 2008-09-16 |