510(k) K891537

CORE BIOPSY NEEDLE, CATALOG CODE #54006 by Dlp, Inc. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1989
Date Received
March 17, 1989
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