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510(k) K832030

Device
HEPARIN COATED STAINLESS STEEL/TEFLON
Applicant
ARGON MEDICAL CORP.
510(k) number
K832030
Product code
DOX  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-29
Date received
1983-06-23
Regulation
862.3550
Classification name
Fluorometer, Lead (dedicated Instruments)
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K014195KAYAK HYDROPHILIC GUIDE WIRESBoston Scientific Corp2002-03-19
K944226MSI PROCEDURE KITMsi, Inc.1995-06-21
K900822HYDRO-SIL(TM) COATED GUIDEWIRESNational-Standard Medical Products1990-07-17

Legacy Summary#

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FDA Review#

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