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510(k) K833430

Device
BLOOD GAS EXPERSYSTEM 8700
Applicant
MEDICAL INTELCOM, INC.
510(k) number
K833430
Product code
LLE  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-10
Date received
1983-10-05
Regulation
510(k) Premarket Notification
Classification name
Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Neurology
Device class
3
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832916INIVOX ELECTRODE/CATHETER SYSCritikon Company, LLC1983-11-14

Legacy Summary#

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FDA Review#

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