510(k) K811726

Device
LEKSELL STEREOACTIC SYSTEM
Applicant
DOWNS SURGICAL LTD.
510(k) number
K811726
Product code
LHF  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-10
Date received
1981-06-18
Regulation
880.5725
Classification name
Warmer, Microwave, Infusion Fluid
Medical specialty
General Hospital
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K8117242M 9810 MICROWAVE OVENTravenol Laboratories, S.A.1981-07-10

Legacy Summary#

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FDA Review#

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