510(k) K904658

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV by Leigh Med Tech, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
October 15, 1990
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