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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K071398
Device Name SCANVIEW, MODEL SC-300
Applicant
Applied Spectral Imaging , Ltd.
Hamatechet St. 4.
Ramat Gavriel Migdal Hahemek,  IL 10551
Applicant Contact SILVIA STOLARSKI
Correspondent
Applied Spectral Imaging , Ltd.
Hamatechet St. 4.
Ramat Gavriel Migdal Hahemek,  IL 10551
Correspondent Contact SILVIA STOLARSKI
Regulation Number864.5260
Classification Product Code
JOY  
Date Received05/21/2007
Decision Date 10/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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