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510(k) K823665

Device
ROTATION BOOT
Applicant
WARM & FORM, ORTHOPEDIC MATERIALS
510(k) number
K823665
Product code
KNP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-30
Date received
1982-12-06
Regulation
890.3475
Classification name
Orthosis, Corrective Shoe
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KNP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831690IPOS ANTI-ADDUCTUS SHOEIpos Luneburg1983-06-24
K831552SORBOTHANE VISCO INNER SOLE PADFred Sammons, Inc.1983-06-08
K823654SLIP-ON SANDALS FOR MEASURING SHORTNESSFred Sammons, Inc.1983-01-21
K810228SORBOTHANEHamilton Kent1981-02-10
K801743PLASTAZOTE SHOEAlimed, Inc.1980-08-07
K790326DRUSHOEJ.E. Hanger & Co. , Ltd.1979-02-26

Legacy Summary#

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FDA Review#

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