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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 K874840
Device Name BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A
Applicant
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Applicant Contact IAQUINTO, JR
Correspondent
Bennett X-Ray Corp.
54 Railroad Ave.
Copiague,  NY  11726
Correspondent Contact IAQUINTO, JR
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/24/1987
Decision Date 01/11/1988
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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