Cleared Traditional

K760736 - BARIMEX, BARIUM SULFATE COMPOUND (FDA 510(k) Clearance)

Nov 1976
Decision
42d
Days
Risk

K760736 is an FDA 510(k) clearance for the BARIMEX, BARIUM SULFATE COMPOUND. This device is classified as a Medium, Contrast, Radiologic.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1976, 42 days after receiving the submission on September 28, 1976.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K760736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1976
Decision Date November 09, 1976
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code KTA — Medium, Contrast, Radiologic
Device Class