The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Micro-craft Oscillating Saw Handpiece.
| Device ID | K822790 |
| 510k Number | K822790 |
| Device Name: | MICRO-CRAFT OSCILLATING SAW HANDPIECE |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-15 |
| Decision Date | 1982-10-22 |