The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Valpro 2 Plus, Vapro 2 Plus Pocket.
| Device ID | K183253 |
| 510k Number | K183253 |
| Device Name: | ValPro 2 Plus, VaPro 2 Plus Pocket |
| 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 | 2018-11-21 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075054039 | K183253 | 000 |
| 00610075054015 | K183253 | 000 |
| 00610075054008 | K183253 | 000 |
| 00610075053995 | K183253 | 000 |
| 00610075053988 | K183253 | 000 |