The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Posisep And Posisep X Hemostat Dressings.
| Device ID | K120958 |
| 510k Number | K120958 |
| Device Name: | POSISEP AND POSISEP X HEMOSTAT DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMOSTASIS, LLC 5000 Township Pkwy Saint Paul, MN 55110 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HEMOSTASIS, LLC 5000 Township Pkwy Saint Paul, MN 55110 |
| 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 | 2012-03-30 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858439001378 | K120958 | 000 |
| 00858439001354 | K120958 | 000 |
| 00858439001316 | K120958 | 000 |
| 00858439001286 | K120958 | 000 |
| 00858439001248 | K120958 | 000 |
| 00858439001910 | K120958 | 000 |
| 00858439001880 | K120958 | 000 |