Infyna Chic
Catheter, Urethral
Hollister Incorporated
The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Infyna Chic.
Pre-market Notification Details
| Device ID | K191633 |
| 510k Number | K191633 |
| Device Name: | Infyna Chic |
| 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 | 2019-06-19 |
| Decision Date | 2019-07-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075072712 | K191633 | 000 |
| 00610075072705 | K191633 | 000 |
| 00610075072682 | K191633 | 000 |
| 00610075072644 | K191633 | 000 |
| 00610075072699 | K191633 | 000 |
Trademark Results [Infyna Chic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFYNA CHIC 88478368 not registered Live/Pending |
Hollister Incorporated 2019-06-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.