The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Value-line Urinary Drainage Bag W/sterile.
Device ID | K844280 |
510k Number | K844280 |
Device Name: | TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Julia A Meyer |
Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-05 |
Decision Date | 1984-12-17 |