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510(k) K822240

Device
ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
Applicant
AMERICAN MCGAW
510(k) number
K822240
Product code
KFX  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-30
Date received
1982-07-27
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#

Contact
FLOYD BENJAMIN
Address
P.O. Box 1187 Santa Ana CA US 92711 92711

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
K830285REGNELL HYDRAULIC FEMORAL PROTHESISBesco Financial Service1983-03-09

Legacy Summary#

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FDA Review#

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