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510(k) K944226

Device
MSI PROCEDURE KIT
Applicant
MSI, INC.
510(k) number
K944226
Product code
DOX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-21
Date received
1994-08-30
Regulation
862.3550
Classification name
Fluorometer, Lead (dedicated Instruments)
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LARRY G JUNKER
Address
615 Jasmine Ave. N. Tarpon Springs FL US 34689 34689

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
K900822HYDRO-SIL(TM) COATED GUIDEWIRESNational-Standard Medical Products1990-07-17
K832030HEPARIN COATED STAINLESS STEEL/TEFLONArgon Medical Corp.1983-09-29

Legacy Summary#

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FDA Review#

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