The following data is part of a premarket notification filed by Hemostasis Llc with the FDA for Posisep Me Fragmentable Ear Dressing.
| Device ID | K210411 |
| 510k Number | K210411 |
| Device Name: | PosiSep ME Fragmentable Ear Dressing |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | Hemostasis LLC 5000 Township Pkwy St Paul, MN 55110 |
| Contact | Lakshmi Ganesh Bollina |
| Correspondent | Lakshmi Ganesh Bollina Hemostasis LLC 5000 Township Pkwy St Paul, MN 55110 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2022-05-05 |