The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,.
| Device ID | K090960 |
| 510k Number | K090960 |
| Device Name: | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, |
| Classification | Catheter, Urethral |
| 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 | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-08-20 |
| Summary: | summary |