510(k) K872124

CHURCHILL ALBUMIN IV ADMINISTRATION SET by Churchill Corp. — Product Code FPA

K872124 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "CHURCHILL ALBUMIN IV ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on October 13, 1987. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Churchill Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1987
Date Received
June 1, 1987
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