The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Interventional Hemostatic Bandage.
| Device ID | K120782 |
| 510k Number | K120782 |
| Device Name: | INTERVENTIONAL HEMOSTATIC BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Sheila Wallin |
| Correspondent | Sheila Wallin 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 | 2012-03-15 |
| Decision Date | 2013-03-20 |
| Summary: | summary |