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510(k) K760869

Device
SPLIT CERVICAL COLLAR/HEAD HALTER
Applicant
ORTHOPEDIC EQUIPMENT CO., INC.
510(k) number
K760869
Product code
HSS  
Decision
Substantially Equivalent (SESE)
Decision date
1976-11-01
Date received
1976-10-18
Regulation
888.5890
Classification name
Halter, Head, Traction
Medical specialty
Orthopedic
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 HSS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771109ORTHOPEDIC SOFT GOODSOrthopedic Systems, Inc.1977-06-27
K770910MEDISHIELD CERVICAL COLLARFraser Sweatman, Inc.1977-05-25

Legacy Summary#

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FDA Review#

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