The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Pitch-patchs.
| Device ID | K211563 |
| 510k Number | K211563 |
| Device Name: | Pitch-Patchs |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB Ls17 7ue |
| Contact | Steve Curran |
| Correspondent | Steve Curran Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB Ls17 7ue |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-20 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267132024 | K211563 | 000 |
| 05060267132017 | K211563 | 000 |