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510(k) K900822

Device
HYDRO-SIL(TM) COATED GUIDEWIRES
Applicant
NATIONAL-STANDARD MEDICAL PRODUCTS
510(k) number
K900822
Product code
DOX  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-17
Date received
1990-02-21
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#

Contact
KARL SWARTZ
Address
4445-360 SW 35th Ter. Gainesville FL US 32608 32608

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
K832030HEPARIN COATED STAINLESS STEEL/TEFLONArgon Medical Corp.1983-09-29

Legacy Summary#

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FDA Review#

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