The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007.
| Device ID | K083153 |
| 510k Number | K083153 |
| Device Name: | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 |
| 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20610075179651 | K083153 | 000 |
| 20610075179644 | K083153 | 000 |
| 20610075179637 | K083153 | 000 |
| 20610075179620 | K083153 | 000 |