The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Posisep And Posisep X Hemostat Dressing/intranasal Splint.
| Device ID | K122494 |
| 510k Number | K122494 |
| Device Name: | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT |
| Classification | Splint, Intranasal Septal |
| 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 | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2013-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858439001422 | K122494 | 000 |
| 00858439001392 | K122494 | 000 |
| 00858439001682 | K122494 | 000 |