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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K844926
Device Name HEAD-SPINE STABILIZER HSS-1
Applicant
Imaging Accessories, Inc.
632 17th Ave.
Salt Lake City,  UT  84103
Applicant Contact PHILIP R FREDERICK
Correspondent
Imaging Accessories, Inc.
632 17th Ave.
Salt Lake City,  UT  84103
Correspondent Contact PHILIP R FREDERICK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/19/1984
Decision Date 04/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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