510(k) K981889

WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE by Worldwide Medical Technologies, LLC — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1998
Date Received
May 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type