510(k) K073257

KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR by Kawasumi Laboratories, Inc. — Product Code FMI

K073257 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR". The FDA issued a decision of Substantially Equivalent on January 25, 2008. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2008
Date Received
November 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type