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510(k) K841153

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

K841153 is an FDA 510(k) premarket notification submitted by Colorado Medical, Inc. for the device "ADAPTOR HR-3000 REUSE". The FDA issued a decision of Substantially Equivalent on July 16, 1984. 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
July 16, 1984
Date Received
March 19, 1984
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)
  • K870689 — 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)
  • 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