510(k) K091382

KRYPTONITE BONE CEMENT by Doctors Research Group, Inc. — Product Code GXP

Clearance Details

Decision
SESU ()
Decision Date
November 16, 2009
Date Received
May 11, 2009
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