510(k) K043523

INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE by Medical Device Technologies, Inc. — Product Code KNW

K043523 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on February 11, 2005. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2005
Date Received
December 20, 2004
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