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510(k) K821260

Device
VITOFIT
Applicant
SELOMAS, INC.
510(k) number
K821260
Product code
FQL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-23
Date received
1982-04-30
Regulation
880.5780
Classification name
Stocking, Medical Support (for General Medical Purposes)
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 FQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944240SOFT SOCKSilipos, Inc.1994-12-27
K823789ELASTIC COMPRESSION ANKLETOrthopaedic Resources Corp.1983-01-07
K823350ELASTIC COMPRESSION ANKLETPodiatry Products Corp.1982-12-03
K821259VITASANSelomas, Inc.1982-06-23
K820484VENES CUSTON RXJung Products, Inc.1982-03-18

Legacy Summary#

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FDA Review#

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