The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Instaflo Bowel Catheter System Kit.
| Device ID | K123804 |
| 510k Number | K123804 |
| Device Name: | INSTAFLO BOWEL CATHETER SYSTEM KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Chris Stukel |
| Correspondent | Chris Stukel HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-04-17 |
| Summary: | summary |