The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Inteventional, Model P/n 182.
| Device ID | K090620 |
| 510k Number | K090620 |
| Device Name: | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 |
| 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 | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-04-08 |
| Summary: | summary |