510(k) K031344

RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE by Ranfac, Corp. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2003
Date Received
April 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type