The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Tubing Set W/ Irrigation & Aspiration Valving.
| Device ID | K922246 |
| 510k Number | K922246 |
| Device Name: | TUBING SET W/ IRRIGATION & ASPIRATION VALVING |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Contact | David J Parins |
| Correspondent | David J Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-13 |
| Decision Date | 1992-09-02 |