The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit.
| Device ID | K013483 |
| 510k Number | K013483 |
| Device Name: | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT |
| Classification | Catheter, Urological |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph Tokarz |
| Correspondent | Joseph Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2002-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610075971241 | K013483 | 000 |
| 10610075101952 | K013483 | 000 |
| 10610075101969 | K013483 | 000 |
| 10610075101976 | K013483 | 000 |
| 10610075101983 | K013483 | 000 |
| 10610075101990 | K013483 | 000 |
| 10610075102010 | K013483 | 000 |
| 10610075102027 | K013483 | 000 |
| 10610075102034 | K013483 | 000 |
| 10610075102041 | K013483 | 000 |
| 10610075102089 | K013483 | 000 |
| 10610075102096 | K013483 | 000 |
| 10610075102102 | K013483 | 000 |
| 10610075102119 | K013483 | 000 |
| 10610075102126 | K013483 | 000 |
| 10610075102133 | K013483 | 000 |
| 10610075102140 | K013483 | 000 |
| 10610075101945 | K013483 | 000 |