The following data is part of a premarket notification filed by Leon's Fecal Sanitary Tub Mfg. with the FDA for Fecal Sanitary Tube.
| Device ID | K813526 |
| 510k Number | K813526 |
| Device Name: | FECAL SANITARY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | LEON'S FECAL SANITARY TUB MFG. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-16 |
| Decision Date | 1982-01-12 |