510(k) K981470

WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE by Worldwide Medical Technologies, LLC — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1998
Date Received
April 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type