FDA.reportPublic FDA data

510(k) K013713

Device
ARM AUTOMATIC REPROCESSING MACHINE
Applicant
Alcavis International Incorporated
510(k) number
K013713
Product code
LIF
Decision
Substantially Equivalent (SESE)
Decision date
2002-07-15
Date received
2001-11-08
Regulation
876.5820
Classification name
Dialyzer Reprocessing System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LUDOVICO GIAVOTTO
Address
8-8 Metropolitan Ct. Gaithersburg MD US 20878 20878

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux Technologies2010-11-03
K043126ASSIST HEADER CLEANERAlcavis International, Inc.2005-02-03
K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach Company2004-11-15
K033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.2004-04-27
K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLC2003-09-26
K992016AMUKIN DAmuchina Intl., Inc.2000-01-10
K991851RENACLEAR DIALYZER CLEANING SYSTEMMinntech Corp.1999-08-30
K974426POTENCY TEST STRIPS, INDICATOR TEST STRIPSReprocessing Products Corp1999-02-10
K974798STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPSEnvironmental Test Systems, Inc.1998-03-20
K970799ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)Alexander Mfg. Co.1997-05-14
K955299DPS 4 DIALYZER PREPARATION SYSTEMSeratronics, Inc.1996-10-21
K931336DRS 4 DIALYZER REPROCESSING SYSTEMSeratronics, Inc.1996-04-18
K941867RENALIN REUSE CARTRenal Scientific Service, Inc.1996-01-22
K941757FORMALIN REUSE CARTNational Medical Care, Medical Products Div., Inc.1996-01-22
K944539DRS 4 ND DIALYZER REPROCESSING SYSTEMSeratronics, Inc.1995-11-29