The following data is part of a premarket notification filed by Koag Llc with the FDA for Vascette Hp (hemostatic Pad).
| Device ID | K220566 |
| 510k Number | K220566 |
| Device Name: | Vascette HP (hemostatic Pad) |
| Classification | Dressing, Wound, Drug |
| Applicant | KOAG LLC 790 Rarity Bay Pkwy Vonore, TN 37885 |
| Contact | David Lang |
| Correspondent | David Lang KOAG LLC 790 Rarity Bay Pkwy Vonore, TN 37885 |
| 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 | 2022-02-28 |
| Decision Date | 2022-07-29 |