The following data is part of a premarket notification filed by Tiller Mind Body, Inc. with the FDA for Libbe Rectal Tube (formerly A Yankauer Suction Tube).
| Device ID | K962259 |
| 510k Number | K962259 |
| Device Name: | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) |
| Classification | Colonic Irrigation System |
| Applicant | TILLER MIND BODY, INC. 2204 N.W. LOOP 410 #2C San Antonio, TX 78230 |
| Contact | Jeri Tiller |
| Correspondent | Jeri Tiller TILLER MIND BODY, INC. 2204 N.W. LOOP 410 #2C San Antonio, TX 78230 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-08-29 |