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510(k) K790557

Device
CRUTCH
Applicant
MADDAK, INC.
510(k) number
K790557
Product code
IPR  
Decision
Substantially Equivalent (SESE)
Decision date
1979-04-03
Date received
1979-03-19
Regulation
890.3150
Classification name
Crutch
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 IPR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821403LIGHT WEIGHT ALUMINUM CRUTCHESManuco Manufacturing Co., Inc.1982-06-21
K800237FOLDING CRUTCHHusa Folding Crutch Co., Inc.1980-02-22
K770146SWIVEL HEAD ADJUSTABLE CRUTCHMaddak, Inc.1977-01-28

Legacy Summary#

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FDA Review#

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