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510(k) K830468

Device
MODEL 200
Applicant
WESTERN LABORATORIES CORP.
510(k) number
K830468
Product code
FTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-12
Date received
1983-02-15
Regulation
886.4445
Classification name
Locator, Magnetic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
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 FTZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K833229SUN BED BY VERRE ET QUARTZ UVA-FRANCEH & M Douglas Enterprises, Inc.1984-01-27

Legacy Summary#

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FDA Review#

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