510(k) K060097

GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 by KLS-Martin L.P. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2006
Date Received
January 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type