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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, Stationary
510(k) Number K935649
Device Name WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY
Applicant
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Applicant Contact ROBERT P COE
Correspondent
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Correspondent Contact ROBERT P COE
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/23/1993
Decision Date 02/09/1994
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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