510(k) K942630

WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE by Mill-Rose Laboratory — Product Code KNW

K942630 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on July 12, 1994. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
June 3, 1994
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