The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Cystoflo Antimicrobial Urinary Drainage.
| Device ID | K832290 |
| 510k Number | K832290 |
| Device Name: | CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-13 |
| Decision Date | 1984-07-31 |