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510(k) K941757

FORMALIN REUSE CART by National Medical Care, Medical Products Div., Inc. — Product Code LIF

K941757 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "FORMALIN REUSE CART". The FDA issued a decision of Substantially Equivalent on January 22, 1996. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1996
Date Received
April 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (December 22, 1995)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)
  • K915628 — DEXTROLYTE II PERITONEAL DIALYSIS PUMP (March 16, 1992)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources