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510(k) K760578

Device
BALANCED CAST SOLE
Applicant
PARKE-DAVIS CO.
510(k) number
K760578
Product code
IPG  
Decision
Substantially Equivalent (SESE)
Decision date
1976-09-27
Date received
1976-09-03
Regulation
890.3025
Classification name
Shoe, Cast
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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 IPG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K024279NESS CHILDREN SYSTEMNess-Neuromuscular Electrical Stimulation Systems2003-02-05
K790652TOGUARDTogard, Inc.1979-04-04
K781363CAST SHOECutler Biomedical1978-08-14
K780617EQUALIZERBallert Orthopedic Corp.1978-04-18
K760575ROCKER-SOLE CAST SANDALRichard'S Medical Equip., Inc.1976-10-06

Legacy Summary#

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FDA Review#

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