The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Womed Nicro-craft Power System.
| Device ID | K791407 |
| 510k Number | K791407 |
| Device Name: | WOMED NICRO-CRAFT POWER SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-31 |
| Decision Date | 1979-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490073233 | K791407 | 000 |
| 00681490070355 | K791407 | 000 |
| 20681490069322 | K791407 | 000 |
| 20681490069315 | K791407 | 000 |
| 20681490069292 | K791407 | 000 |
| 00681490069281 | K791407 | 000 |
| 00681490051569 | K791407 | 000 |