The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Irrigation Sets.
| Device ID | K023808 |
| 510k Number | K023808 |
| Device Name: | IRRIGATION SETS |
| Classification | System, Irrigation, Urological |
| Applicant | INTERNATIONAL MEDSURG CONNECTION P.O. BOX 848 Grayslake, IL 60030 |
| Contact | Michele H Vovolka |
| Correspondent | Michele H Vovolka INTERNATIONAL MEDSURG CONNECTION P.O. BOX 848 Grayslake, IL 60030 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2003-03-10 |
| Summary: | summary |