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510(k) K882640

Device
TECNOL SECURE-ALL PELVIC TRACTION BELT
Applicant
TECNOL NEW JERSEY WOUND CARE, INC.
510(k) number
K882640
Product code
KQZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-27
Date received
1988-06-27
Regulation
888.5890
Classification name
Component, Traction, Non-invasive
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEONA M HAMMEL
Address
7201 Industrial Park Blvd. Fort Worth TX US 76180 76180

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884132TECNOL BUCKS TRACTION W/HEEL PROTECTORTechnol, Inc.1988-10-11
K871900OVER DRAPE LEG HOLDERAvec Scientific Design Corp.1987-06-16
K871296T.E.D.(TM) TRACTION DEVICEThe Kendal Co.1987-04-15
K854270MURPHY ADJUSTABLE SPLINTComfortex, Inc.1985-12-09
K831002TPG 1000Physical Diagnostics, Inc.1983-06-24
K823660UNIVERSAL BUCKS TRACTIONWarm & Form, Orthopedic Materials1982-12-30
K823163UNIVERSAL BUCKS TRACTIONWarm & Form, Orthopedic Materials1982-11-10
K821252HOFFMAN UNIVERSAL FOOT SUPPORTHowmedica Corp.1982-06-22
K802869BACKTRAC 90-90 TRACTIONBacktrac1980-12-11
K781754SPLINT, HOAKE INFLATABLE AIRDepuy, Inc.1978-11-08

Legacy Summary#

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FDA Review#

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