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510(k) K831239

Device
WALRUS PERCUTANEOUS INTRODUCER SET
Applicant
MEDICAL PARAMETERS, INC.
510(k) number
K831239
Product code
DOY  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-25
Date received
1983-04-15
Regulation
862.3320
Classification name
Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep.
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 DOY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910154USCI ILLUMEN-8 8F PTCA GUIDING CATHETERC.R. Bard, Inc.1991-04-09
K832396CENTRAL VENOUS ACCESS CATHETER CVACGish Biomedical, Inc.1983-08-31
K831188CONNECTOR TUBEMedrad, Inc.1983-05-09
K831191VASCULAR CATHETERMedrad, Inc.1983-05-09

Legacy Summary#

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FDA Review#

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