The following data is part of a premarket notification filed by Endovations with the FDA for Rapid Endoscopic Lavage System.
| Device ID | K862058 |
| 510k Number | K862058 |
| Device Name: | RAPID ENDOSCOPIC LAVAGE SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Karen S Butt |
| Correspondent | Karen S Butt ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-08-11 |