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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, vessel, surgical
510(k) Number K183438
Device Name Geomed Vascular Dilators
Geomed Medizin-Technik GmbH & Co.
Ludwigstaler Strasse 27
tuttlingen,  DE 78532
Applicant Contact hanno haug
Business Support International
Amstel 320-1
amsterdam,  NL 1017ap
Correspondent Contact angelika scherp
Regulation Number870.4475
Classification Product Code
Date Received12/12/2018
Decision Date 09/03/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No