The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Lavaging Catheters.
| Device ID | K822061 |
| 510k Number | K822061 |
| Device Name: | LAVAGING CATHETERS |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | AMERICAN ENDOSCOPY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-13 |
| Decision Date | 1982-07-20 |