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510(k) K831002

Device
TPG 1000
Applicant
PHYSICAL DIAGNOSTICS, INC.
510(k) number
K831002
Product code
KQZ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-24
Date received
1983-03-29
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#

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 KQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884132TECNOL BUCKS TRACTION W/HEEL PROTECTORTechnol, Inc.1988-10-11
K882640TECNOL SECURE-ALL PELVIC TRACTION BELTTecnol New Jersey Wound Care, Inc.1988-07-27
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
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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