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 |