510(k) K872743

BAXA TUBING SETS (FOR PHARMACY PUMP) by Baxa Corp., Sub. of Cook Group, Inc. — Product Code FMF

K872743 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "BAXA TUBING SETS (FOR PHARMACY PUMP)". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
July 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type