The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Onli Intermittent Catheter.
| Device ID | K163179 |
| 510k Number | K163179 |
| Device Name: | Onli Intermittent Catheter |
| Classification | Catheter, Urethral |
| Applicant | HOLLISTER INCORPORATED 2000 HOLLISTER DRIVE Libertyville, IL 60048 |
| Contact | Jeanne Lee |
| Correspondent | Jeanne Lee 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 | 2016-11-14 |
| Decision Date | 2017-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20610075056334 | K163179 | 000 |
| 20610075056242 | K163179 | 000 |
| 20610075056259 | K163179 | 000 |
| 20610075056266 | K163179 | 000 |
| 20610075056273 | K163179 | 000 |
| 20610075056280 | K163179 | 000 |
| 20610075056303 | K163179 | 000 |
| 20610075056310 | K163179 | 000 |
| 20610075056327 | K163179 | 000 |
| 20610075056235 | K163179 | 000 |