The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Vapro Plus Pocket, Vapro Plus.
| Device ID | K193148 |
| 510k Number | K193148 |
| Device Name: | VaPro Plus Pocket, VaPro Plus |
| Classification | Catheter, Urethral |
| Applicant | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing 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 | 2019-11-13 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075068760 | K193148 | 000 |