510(k) K881160

CRANK FRAME RETRACTOR by T. Korossurgical Instruments Corp. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1988
Date Received
March 18, 1988
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