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510(k) K974064

MICRO X RESIDUAL TEST STRIPS by Reprocessing Products Corp — Product Code MSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1998
Date Received
October 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K950602 — PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (November 30, 1995)

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