510(k) K902077

T19S BIOPSY NEEDLE by Ohio Medical Instrument Co., Inc. — Product Code KNW

K902077 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "T19S BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
May 8, 1990
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