The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Modified Saw Blades To The Sagital Saw.
| Device ID | K884839 |
| 510k Number | K884839 |
| Device Name: | MODIFIED SAW BLADES TO THE SAGITAL SAW |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| 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 | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1988-12-07 |