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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K192348
Device Name SICAT Implant V2.0
Applicant
SICAT GmbH & Co. KG
Brunnenallee 6
Bonn,  DE 53177
Applicant Contact Manfred Breuer
Correspondent
SICAT GmbH & Co. KG
Brunnenallee 6
Bonn,  DE 53177
Correspondent Contact Manfred Breuer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/29/2019
Decision Date 12/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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