The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Sport And Quikclot Sport Silver.
| Device ID | K070010 |
| 510k Number | K070010 |
| Device Name: | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Giacomo Basadonna |
| Correspondent | Giacomo Basadonna Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-01-03 |
| Decision Date | 2007-01-25 |
| Summary: | summary |