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510(k) K960027

Device
HIGH VOLUME I.V. & IRRIGATION TOWER
Applicant
ALLEN MEDICAL SYSTEMS, INC.
510(k) number
K960027
Product code
FOX  
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-12
Date received
1996-01-02
Regulation
880.6990
Classification name
Stand, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SUZANNE K RATZLOFF
Address
5198 Richmond Rd. Bedford Heights OH US 44146 44146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980336IV STANDSClinton Industries, Inc.1998-04-06
K964782MEDRAD CONTRAST HOLDERMedrad, Inc.1997-02-25
K961470PORT-A-POLEPrins Medical Ind., Inc.1996-07-22
K952196IV POLE/STANDValentine Intl. , Ltd.1995-07-31
K950367IV SHUTTLEEquipment Concepts, Inc.1995-04-26
K946201STAND, INFUSIONMedical Specialties, Inc.1995-04-18
K944580FLEXSYS MOBILEMATE EQUIPMENT STANDHill-Rom, Inc.1995-03-17
K932498MOBILE CARE IV STANDMobile Care, Inc.1993-10-27
K925066PNEUMATIC IRRIGATION STANDARDArthrodyn, Inc.1993-07-28
K912010I.V. SKY-HOOKDina - Industria, Comercio E Exportacao , Ltd.1991-08-19
K900981INTRAVENOUS STAND OR IV STANDTravl-Med Infusion Device Transport System1990-03-27
K895776AIV SYSTEMS' IV POLESAutomated IV Systems, Inc.1990-02-28
K893597HYDRAULIC IV POLEArthro-Medic, Inc.1989-10-10
K883133HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDERFerguson Medical1988-11-21
K884341CRITICAL CARE I.V. STAND STABILIZING BRACKETRbd Medical, Inc.1988-11-07

Legacy Summary#

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FDA Review#

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