The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Cystoflo Urinary Drainage Bag W/antimic.
| Device ID | K823716 |
| 510k Number | K823716 |
| Device Name: | CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | TRAVENOL LABORATORIES, S.A. 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 | 1982-12-10 |
| Decision Date | 1983-01-14 |