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510(k) K932184

Device
STERILE LEMAITRE GLOW 'N TELL TAPE
Applicant
VASCUTECH, INC.
510(k) number
K932184
Product code
KFX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-22
Date received
1993-05-05
Regulation
890.3500
Classification name
Assembly, Thigh/knee/shank/ankle/foot, External
Medical specialty
Physical Medicine
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE LEMAITRE
Address
790 Tpke. St. North Andover MA US 01845 01845

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
K833868IPOS G.L.P. SYSTEMIpos Luneburg1983-11-28
K830285REGNELL HYDRAULIC FEMORAL PROTHESISBesco Financial Service1983-03-09
K822240ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.American Mcgaw1982-12-30

Legacy Summary#

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FDA Review#

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