The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Infyna Chic.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00610075072712 | K191633 | 000 |
00610075072705 | K191633 | 000 |
00610075072682 | K191633 | 000 |
00610075072644 | K191633 | 000 |
00610075072699 | K191633 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() INFYNA CHIC 88478368 not registered Live/Pending |
Hollister Incorporated 2019-06-18 |