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510(k) K823790

Device
VENTRICULAR ACCESS SYSTEM
Applicant
AMERICAN HEYER SCHULTE
510(k) number
K823790
Product code
LKG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-28
Date received
1982-12-16
Regulation
882.5550
Classification name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Medical specialty
Neurology
Review panel
General Hospital
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 LKG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950315CORDIS CSF RESERVOIRCordis Corp.1995-05-09
K881493PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.Pharmacia Deltec, Inc.1988-05-20
K881690PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.1988-05-20
K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.1988-02-11
K874498CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.1988-02-11
K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.1984-05-25
K833672HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.1984-03-06

Legacy Summary#

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FDA Review#

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