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FKL — Insert, Pump, Blood Class II

FDA Device Classification

Classification Details

Product Code
FKL
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K854084organon teknikaPEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENTNovember 8, 1985