510(k) K024359

VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 by Vista Scientific, LLC — Product Code MYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2003
Date Received
December 30, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type