510(k) K813092

ACCUPRO I.V. ADMINISTRATION SET by American Mcgaw — Product Code FPA

K813092 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "ACCUPRO I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. American Mcgaw has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 2, 1981
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