510(k) K926035
K926035 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD LEG BAG HOLDER". The FDA issued a decision of Substantially Equivalent on December 17, 1992. 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
- December 17, 1992
- Date Received
- December 1, 1992
- 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