The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Ectra Ligament Release System.
| Device ID | K953387 |
| 510k Number | K953387 |
| Device Name: | ECTRA LIGAMENT RELEASE SYSTEM |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Elizabeth A Ryan |
| Correspondent | Elizabeth A Ryan SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-19 |
| Decision Date | 1995-08-09 |