The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Continuous Loop Fixation Device.
| Device ID | K052652 |
| 510k Number | K052652 |
| Device Name: | SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2005-10-21 |
| Summary: | summary |