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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, Angiographic
510(k) Number K141136
Device Name LEICA FL800
Applicant
Leica Biosystems Richmond
5205 Rt 12
Solon Mills,  IL  60071
Applicant Contact BARBARA-ANN CONWAY-MYERS
Correspondent
Leica Biosystems Richmond
5205 Rt 12
Solon Mills,  IL  60071
Correspondent Contact BARBARA-ANN CONWAY-MYERS
Regulation Number892.1600
Classification Product Code
IZI  
Date Received05/01/2014
Decision Date 08/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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