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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, optical coherence tomography (oct)
510(k) Number K132800
Device Name SKINTELL
Applicant
AGFA HEALTHCARE N.V.
10 SOUTH ACADEMY STREET
GREENVILLE,  SC  29601
Applicant Contact SHAEANN CAVANAGH
Correspondent
AGFA HEALTHCARE N.V.
10 SOUTH ACADEMY STREET
GREENVILLE,  SC  29601
Correspondent Contact SHAEANN CAVANAGH
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received09/06/2013
Decision Date 03/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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