The following data is part of a premarket notification filed by Invent Medical Usa, Llc with the FDA for Talee, Talee Postop.
| Device ID | K220681 |
| 510k Number | K220681 |
| Device Name: | Talee, Talee PostOP |
| Classification | Orthosis, Cranial |
| Applicant | Invent Medical USA, LLC 1800 Mearns Rd, Suite Y Warminster, PA 18974 |
| Contact | Jiri Rosicky |
| Correspondent | Jiri Rosicky Invent Medical USA, LLC 1800 Mearns Rd, Suite Y Warminster, PA 18974 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-08 |
| Decision Date | 2022-09-22 |