The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot 1st Response & Quikclot Acs+.
| Device ID | K061767 |
| 510k Number | K061767 |
| Device Name: | QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ |
| 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 | 2006-06-23 |
| Decision Date | 2006-07-19 |
| Summary: | summary |