The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Micro-irrigator.
| Device ID | K813475 |
| 510k Number | K813475 |
| Device Name: | XOMED MICRO-IRRIGATOR |
| Classification | Lavage, Jet |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1982-02-04 |