510(k) K011736

DRG QUICKMIX by Doctor'S Research Group, Inc. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2002
Date Received
June 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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