The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Pacesetter (tm) 3500 Arthroscopic Surgical System.
| Device ID | K880150 |
| 510k Number | K880150 |
| Device Name: | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | John J Sokolowski |
| Correspondent | John J Sokolowski DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-03-04 |