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 |