510(k) K890820

LOCKING WIRE GUIDE STYLET by Medical Engineering and Development Institute — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
February 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type