510(k) K954999

LILY MULTICANNULA GUIDE by Lily Imaging Solutions Co. — Product Code KNW

K954999 is an FDA 510(k) premarket notification submitted by Lily Imaging Solutions Co. for the device "LILY MULTICANNULA GUIDE". The FDA issued a decision of Substantially Equivalent on April 4, 1996. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Lily Imaging Solutions Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1996
Date Received
November 1, 1995
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