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 |