The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Nexstat Plus And Nexfoam Plus Topical Hemostat Dressing.
| Device ID | K122886 |
| 510k Number | K122886 |
| Device Name: | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts, MN 55127 |
| 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 | 2012-09-20 |
| Decision Date | 2012-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858439001408 | K122886 | 000 |
| 00858439001293 | K122886 | 000 |