The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Welcon Hue-vu Urinary Drainage Bag.
| Device ID | K971764 |
| 510k Number | K971764 |
| Device Name: | WELCON HUE-VU URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Contact | George Hird |
| Correspondent | George Hird WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-13 |
| Decision Date | 1997-07-29 |
| Summary: | summary |