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510(k) K870689

HR-3000 REUSE ADAPTOR by Colorado Medical, Inc. — Product Code LIF

K870689 is an FDA 510(k) premarket notification submitted by Colorado Medical, Inc. for the device "HR-3000 REUSE ADAPTOR". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Colorado Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
February 19, 1987
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 Colorado Medical, Inc.

  • K870471 — MODIFIED HR-3000 REUSE ADAPTOR (April 10, 1987)
  • K863471 — COLORADO MEDICAL MODEL PTC 1000 (October 2, 1986)
  • K853735 — COLORADO MEDICAL MODEL CTM-3000 (October 4, 1985)
  • K841153 — ADAPTOR HR-3000 REUSE (July 16, 1984)
  • K830190 — AHR-3000 RE-USE ADAPTOR (May 27, 1983)

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