510(k) K760736
K760736 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARIMEX, BARIUM SULFATE COMPOUND". The FDA issued a decision of Substantially Equivalent on November 9, 1976. The device falls under product code KTA (Medium, Contrast, Radiologic), a Class U device. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1976
- Date Received
- September 28, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medium, Contrast, Radiologic
- Device Class
- Class U
- Regulation Number
- Review Panel
- RA
- Submission Type