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510(k) K790955

Device
COVER GARD
Applicant
FEM-GARD, INC.
510(k) number
K790955
Product code
FRK  
Decision
Substantially Equivalent (SESE)
Decision date
1979-06-20
Date received
1979-05-22
Regulation
880.6140
Classification name
Chair, Examination And Treatment
Medical specialty
General Hospital
Review panel
General Hospital
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 FRK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896275JEDMED J-II CHAIRJedmed Instrument Co.1989-12-18
K791016ULTICARE 2500 TREATMENT CHAIRAmerican Health Care Industries, Inc.1979-06-27
K790954HEEL GARDFem-Gard, Inc.1979-06-20

Legacy Summary#

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FDA Review#

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