The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Xclose Tissue Repair System, Model Xc-200-01.
| Device ID | K091432 |
| 510k Number | K091432 |
| Device Name: | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy 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 | 2009-05-14 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860323000206 | K091432 | 000 |