510(k) K872953

DISPOSABLE I.V. ADMINISTRATION SET by Mac Lee Medical Products — Product Code FPA

K872953 is an FDA 510(k) premarket notification submitted by Mac Lee Medical Products for the device "DISPOSABLE I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on January 6, 1988. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Mac Lee Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1988
Date Received
July 29, 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