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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, Mobile
510(k) Number K883092
Device Name BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
Applicant
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Applicant Contact HOWARD ROSENBERG
Correspondent
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Correspondent Contact HOWARD ROSENBERG
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/22/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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