510(k) K861822

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI by Valley Forge Scientific Corp. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1986
Date Received
May 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type