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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated digital image manual interpretation microscope
510(k) Number K130021
Device Name PHILIPS HERCEPTEST DIGITAL SCORE
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST, NB,  NL 5684 PC
Applicant Contact DIRK VOSSEN
Correspondent
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST, NB,  NL 5684 PC
Correspondent Contact DIRK VOSSEN
Regulation Number864.1860
Classification Product Code
OEO  
Date Received01/03/2013
Decision Date 09/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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