The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for D2 Hemostantic Dressing.
| Device ID | K140757 |
| 510k Number | K140757 |
| Device Name: | D2 HEMOSTANTIC DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA, LLC 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Sheila Wallin |
| Correspondent | Sheila Wallin Z-MEDICA, LLC 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 | 2014-03-26 |
| Decision Date | 2014-07-17 |
| Summary: | summary |