510(k) K950895

HARMAC EXTENSION INFUSION SET by Harmac Medical Products, Inc. — Product Code FPA

K950895 is an FDA 510(k) premarket notification submitted by Harmac Medical Products, Inc. for the device "HARMAC EXTENSION INFUSION SET". The FDA issued a decision of Substantially Equivalent on September 1, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Harmac Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1995
Date Received
February 27, 1995
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