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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Wheeled
510(k) Number K844578
Device Name NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA
Applicant
Engineering Dynamics Corp.
120 Stedman St.
Lowell,  MA  01851
Applicant Contact JOSEPH RESS
Correspondent
Engineering Dynamics Corp.
120 Stedman St.
Lowell,  MA  01851
Correspondent Contact JOSEPH RESS
Regulation Number880.6910
Classification Product Code
FPO  
Date Received11/23/1984
Decision Date 05/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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