The following data is part of a premarket notification filed by Hollister, Incorporated with the FDA for Vapro Plus Intermittent Catheter.
| Device ID | K110862 |
| 510k Number | K110862 |
| Device Name: | VAPRO PLUS INTERMITTENT CATHETER |
| Classification | Catheter, Urethral |
| Applicant | HOLLISTER, INCORPORATED 2000 HOLLISTER DRIVE ;ibertyville, IL 60048 |
| Contact | Chris Stukel |
| Correspondent | Chris Stukel HOLLISTER, INCORPORATED 2000 HOLLISTER DRIVE ;ibertyville, IL 60048 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-29 |
| Decision Date | 2011-04-26 |
| Summary: | summary |