Geomed Vascular Dilators

Dilator, Vessel, Surgical

Geomed Medizin-Technik GmbH & Co.

The following data is part of a premarket notification filed by Geomed Medizin-technik Gmbh & Co. with the FDA for Geomed Vascular Dilators.

Pre-market Notification Details

Device IDK183438
510k NumberK183438
Device Name:Geomed Vascular Dilators
ClassificationDilator, Vessel, Surgical
Applicant Geomed Medizin-Technik GmbH & Co. Ludwigstaler Strasse 27 Tuttlingen,  DE 78532
ContactHanno Haug
CorrespondentAngelika Scherp
Business Support International Amstel 320-1 Amsterdam,  NL 1017ap
Product CodeDWP  
CFR Regulation Number870.4475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-12
Decision Date2019-09-03
Summary:summary

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