MYU · Class II · 21 CFR 882.5300

FDA Product Code MYU: Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Leading manufacturers include Cardinalhealth and Parallax Medical, Inc..

6
Total
6
Cleared
105d
Avg days
1999
Since

FDA 510(k) Cleared Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty Devices (Product Code MYU)

6 devices
1–6 of 6
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388
Cardinalhealth
Neurology · 88d
Cleared Aug 13, 1999
PARALLAX TRACER RADIOPAQUE PARTICLES
K991893
Parallax Medical, Inc.
Neurology · 71d

About Product Code MYU - Regulatory Context