510(k) K851831

MANAN FRANSEENE NEEDLE by Manan Manufacturing Co., Inc. — Product Code KNW

K851831 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN FRANSEENE NEEDLE". The FDA issued a decision of Substantially Equivalent on May 14, 1985. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1985
Date Received
April 26, 1985
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