510(k) K950602

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS by Reprocessing Products Corp — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1995
Date Received
February 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type