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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
Applicant
Geomed Medizin-Technik GmbH & Co.
Ludwigstaler Strasse 27
Tuttlingen,  DE 78532
Applicant Contact Hanno Haug
Correspondent
Business Support International
Amstel 320-1
Amsterdam,  NL 1017AP
Correspondent Contact Angelika Scherp
Regulation Number870.4475
Classification Product Code
DWP  
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
Predetermined Change
Control Plan Authorized		 No
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