510(k) K990839

TRU-CORE I REUSABLE BIOPSY INSTRUMENT by Medical Device Technologies, Inc. — Product Code KNW

K990839 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "TRU-CORE I REUSABLE BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 20, 1999. 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
May 20, 1999
Date Received
March 15, 1999
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