The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Ps3500 Arthroscopic Surgical System.
| Device ID | K892062 |
| 510k Number | K892062 |
| Device Name: | PS3500 ARTHROSCOPIC SURGICAL SYSTEM |
| Classification | Arthroscope |
| Applicant | DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | J Sokolowski |
| Correspondent | J Sokolowski 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 | 1989-03-30 |
| Decision Date | 1989-06-23 |