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510(k) K821619

Device
THE SPORTS HAND
Applicant
THERAPEUTIC RECREATION SYSTEMS, INC.
510(k) number
K821619
Product code
IRA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-20
Date received
1982-06-02
Regulation
890.3420
Classification name
Hand, External Limb Component, Mechanical
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 IRA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K791931PREHENSILE HANDTherapeutic Recreation Systems, Inc.1979-10-04

Legacy Summary#

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FDA Review#

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