The following data is part of a premarket notification filed by Tiller Mind Body, Inc. with the FDA for Lower Bowel Evacuation System.
| Device ID | K941279 |
| 510k Number | K941279 |
| Device Name: | LOWER BOWEL EVACUATION SYSTEM |
| Classification | Colonic Irrigation System |
| Applicant | TILLER MIND BODY, INC. 2204 N.W. LOOP 410 #2C San Antonio, TX 78230 |
| Contact | Jeri C Tiller |
| Correspondent | Jeri C 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 | 1994-03-16 |
| Decision Date | 1995-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868538000400 | K941279 | 000 |