The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Vapro Plus Pocket Intermittent Catheter.
| Device ID | K152268 |
| 510k Number | K152268 |
| Device Name: | VAPRO PLUS POCKET Intermittent Catheter |
| Classification | Catheter, Urethral |
| Applicant | HOLLISTER INCORPORATED 2000 HOLLISTER DR Libertyville, IL 60048 |
| Contact | Jeanne Lee |
| Correspondent | Jeanne Lee HOLLISTER INCORPORATED 2000 HOLLISTER DR Libertyville, 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 | 2015-08-11 |
| Decision Date | 2015-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610075054074 | K152268 | 000 |
| 00610075054053 | K152268 | 000 |
| 00610075054060 | K152268 | 000 |
| 00610075054077 | K152268 | 000 |
| 10610075053985 | K152268 | 000 |
| 10610075053992 | K152268 | 000 |
| 10610075054005 | K152268 | 000 |
| 10610075054012 | K152268 | 000 |
| 10610075054036 | K152268 | 000 |
| 10610075054043 | K152268 | 000 |
| 10610075054050 | K152268 | 000 |
| 10610075054067 | K152268 | 000 |
| 00610075054046 | K152268 | 000 |