The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Instaflo Bowel Catheter System Kit.
| Device ID | K100273 |
| 510k Number | K100273 |
| Device Name: | INSTAFLO BOWEL CATHETER SYSTEM KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-29 |
| Decision Date | 2010-04-22 |
| Summary: | summary |