510(k) K830235

FRANZEN NEEDLE GUIDE by Precision Dynamics Corp. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type