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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 K894643
Device Name RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT
Applicant
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Applicant Contact ED MCDERMOTT
Correspondent
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Correspondent Contact ED MCDERMOTT
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/24/1989
Decision Date 12/14/1989
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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