The following data is part of a premarket notification filed by Surgidyne, Inc. with the FDA for Leonard Tube.
| Device ID | K892334 |
| 510k Number | K892334 |
| Device Name: | LEONARD TUBE |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | SURGIDYNE, INC. 9605 WEST JEFFERSON TRAIL Inver Grove Heights, MN 55077 -4423 |
| Contact | B Mcneil |
| Correspondent | B Mcneil SURGIDYNE, INC. 9605 WEST JEFFERSON TRAIL Inver Grove Heights, MN 55077 -4423 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-05-31 |