510(k) K882503

30 IV EXTENSION SET W/TWO MALE LUER LOCKS by Churchill Medical Systems, Inc. — Product Code FPA

K882503 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device "30 IV EXTENSION SET W/TWO MALE LUER LOCKS". The FDA issued a decision of Substantially Equivalent on August 25, 1988. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Churchill Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1988
Date Received
June 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type