The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Vapro Pocket.
| Device ID | K143594 |
| 510k Number | K143594 |
| Device Name: | VaPro Pocket |
| Classification | Catheter, Urethral |
| Applicant | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Contact | Jeanne Lee |
| Correspondent | Jeanne Lee Hollister Incorporated 2000 Hollister Drive 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 | 2014-12-18 |
| Decision Date | 2015-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075087754 | K143594 | 000 |
| 00610075087730 | K143594 | 000 |
| 00610075072378 | K143594 | 000 |