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510(k) K831149

Device
PERSONAL KNEE CRUTCH PAD
Applicant
TECNOL NEW JERSEY WOUND CARE, INC.
510(k) number
K831149
Product code
INP  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-03
Date received
1983-04-08
Regulation
890.3790
Classification name
Tips And Pads, Cane, Crutch And Walker
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
368 Fairview Ave. Hammonton NJ US 08037 08037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code INP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831889SURGEON'S CHOICE CRUTCH HANDLEW.K. Wheeler, Inc.1983-07-07
K811493CRUTCH & WALKER PADSFred Sammons, Inc.1981-06-12
K810650CRUTCH TIPS & GRIPSFirst Industries, Inc.1981-03-26
K803136CONPHAR CRUTCH TIPSConphar, Inc.1981-01-08
K803140CONPHAR CRUTCH GRIPSConphar, Inc.1981-01-08
K803144CONPHAR CRUTCH PADSConphar, Inc.1981-01-08
K800076CRUTCH TIPS, PADS & HAND GRIPSNew World Imports, Inc.1980-01-28

Legacy Summary#

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FDA Review#

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