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510(k) K951344

RMI HEMOCONCENTRATOR by Research Medical, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
March 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Research Medical, Inc.

  • K970739 — RMI HEMOCONCENTRATOR PREFERENCE PACK (July 8, 1997)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K961927 — RMI HEMOCONCENTRACTOR TUBING SET (August 13, 1996)
  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K920936 — RMI EXTERNAL CORONARY ARTERY OCCLUDER (December 18, 1992)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K910221 — RMI VASCULAR TOURNIQUET KIT (May 16, 1991)
  • K901231 — RMI CARDIOPLEGIA DELIVERY KITS (June 8, 1990)

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