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510(k) K830285

Device
REGNELL HYDRAULIC FEMORAL PROTHESIS
Applicant
BESCO FINANCIAL SERVICE
510(k) number
K830285
Product code
KFX  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-09
Date received
1983-01-27
Regulation
890.3500
Classification name
Assembly, Thigh/knee/shank/ankle/foot, External
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
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 KFX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932184STERILE LEMAITRE GLOW 'N TELL TAPEVascutech, Inc.1993-07-22
K833868IPOS G.L.P. SYSTEMIpos Luneburg1983-11-28
K822240ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.American Mcgaw1982-12-30

Legacy Summary#

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FDA Review#

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