The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Modified Endoscopic Carpal Tunnel Release System.
| Device ID | K903620 |
| 510k Number | K903620 |
| Device Name: | MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon 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 | 1990-08-07 |
| Decision Date | 1990-10-12 |