510(k) K780032
K780032 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "URINARY LEG BAG". The FDA issued a decision of Substantially Equivalent on January 17, 1978. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1978
- Date Received
- January 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type