K780032 is an FDA 510(k) clearance for the URINARY LEG BAG. This device is classified as a Bag, Urine Collection, Leg, For External Use, Sterile (Class I - General Controls, product code FAQ).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1978, 8 days after receiving the submission on January 9, 1978.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K780032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1978 |
| Decision Date | January 17, 1978 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAQ — Bag, Urine Collection, Leg, For External Use, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |