FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

V SET

K Number: K020419 · Decision Aug 29, 2003
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
2
Review Days
568

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Basic Information

Device Name
V SET
K Number
K020419
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
P.T. Greenleaf
Date Received
February 7, 2002
Decision Date
August 29, 2003
Product Code
FPA
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FPA Set, Administration, Intravascular

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Other Clearances by P.T. Greenleaf

K Number Device Name
K020418 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES