The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Ectra Ii Ligament Release System.
| Device ID | K954627 |
| 510k Number | K954627 |
| Device Name: | ECTRA II 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-06 |
| Decision Date | 1995-12-18 |