The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Urinary Leg Bag.
| Device ID | K780032 |
| 510k Number | K780032 |
| Device Name: | URINARY LEG BAG |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-09 |
| Decision Date | 1978-01-17 |