The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Xclose Tissue Repair System, Model Srs.
| Device ID | K062307 |
| 510k Number | K062307 |
| Device Name: | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Contact | Timothy Miller |
| Correspondent | Timothy Miller ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-09-01 |
| Summary: | summary |