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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 K173241
Device Name MED-TAB
Applicant
Plum Medical Solutions GmbH
Lange Strabe 16
Rostock,  DE 18055
Applicant Contact Arpad Bischof
Correspondent
O Tech, Inc.
8317 Belew Dr.
Mckinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/06/2017
Decision Date 03/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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