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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, Mammographic
510(k) Number K992280
Device Name LORAD 1-650 (INTERNATIONAL 650)
Applicant
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact KELVIN BURROUGHS
Correspondent
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact KELVIN BURROUGHS
Regulation Number892.1710
Classification Product Code
IZH  
Date Received07/07/1999
Decision Date 09/03/1999
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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