The following data is part of a premarket notification filed by Xiros Plc with the FDA for Poly-tapes (various Sizes And Woven Construction Variants).
| Device ID | K002172 |
| 510k Number | K002172 |
| Device Name: | POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | XIROS PLC 28-30 BLENHEIM TERRACE Leeds, GB Ls2 9hd |
| Contact | Jim Rowland |
| Correspondent | Jim Rowland XIROS PLC 28-30 BLENHEIM TERRACE Leeds, GB Ls2 9hd |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-19 |
| Decision Date | 2001-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267130563 | K002172 | 000 |