510(k) K770910

Device
MEDISHIELD CERVICAL COLLAR
Applicant
Fraser Sweatman, Inc.
510(k) number
K770910
Product code
HSS
Decision
Substantially Equivalent (SESE)
Decision date
1977-05-25
Date received
1977-05-19
Regulation
888.5890
Classification name
Halter, Head, Traction
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
N

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
K760869SPLIT CERVICAL COLLAR/HEAD HALTEROrthopedic Equipment Co., Inc.1976-11-01