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510(k) K832705

ULTRAMAX by Medicorp, Inc. — Product Code LIF

K832705 is an FDA 510(k) premarket notification submitted by Medicorp, Inc. for the device "ULTRAMAX". The FDA issued a decision of Substantially Equivalent on June 25, 1984. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Medicorp, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
August 12, 1983
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 Medicorp, Inc.

  • K860026 — ULTRAMAX III, DIALYZER REPROCESSING DEVICE (March 14, 1986)
  • K844850 — MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (April 2, 1985)
  • K791164 — NEGATOVE PRESSURE CONVERTOR (October 4, 1979)
  • K791396 — MEDI-TRAK PORTABLE TRACTION DEVICE (August 16, 1979)

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