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 |