The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Female Urinary Collect Sys.
| Device ID | K820234 |
| 510k Number | K820234 |
| Device Name: | HOLLISTER FEMALE URINARY COLLECT SYS |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | HOLLISTER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-28 |
| Decision Date | 1982-02-10 |