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510(k) K803239

Device
SOFTGOOD PRODUCTS AND SPLINTS
Applicant
DANEK MEDICAL, INC.
510(k) number
K803239
Product code
IPX  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-09
Date received
1980-12-23
Regulation
890.3490
Classification name
Orthosis, Rib Fracture, Soft
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 IPX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823662RIB BELT (UNIVERSAL)Warm & Form, Orthopedic Materials1982-12-30
K823158RIB BELT (UNIVERSAL)Warm & Form, Orthopedic Materials1982-11-10

Legacy Summary#

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FDA Review#

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