The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100g - 1.9mm - 2.4mm., Model 100172.
| Device ID | K050769 |
| 510k Number | K050769 |
| Device Name: | QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Robert V Packard |
| Correspondent | Robert V Packard 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 | No |
| Date Received | 2005-03-25 |
| Decision Date | 2005-04-14 |
| Summary: | summary |