ASSISTO Universal Applicator Clamping Device

System, Applicator, Radionuclide, Remote-controlled

Geomed Medizin-Technik GmbH & Co. KG

The following data is part of a premarket notification filed by Geomed Medizin-technik Gmbh & Co. Kg with the FDA for Assisto Universal Applicator Clamping Device.

Pre-market Notification Details

Device IDK201279
510k NumberK201279
Device Name:ASSISTO Universal Applicator Clamping Device
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant Geomed Medizin-Technik GmbH & Co. KG Ludwigstaler Strasse 27 Tuttlingen,  DE 78532
ContactHanno Haug
CorrespondentAngelika Scherp
Business Support International Aalsmeerweg 123-3 Amsterdam,  NL 1059ah
Product CodeJAQ  
Subsequent Product CodeGCJ
Subsequent Product CodeGWG
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-13
Decision Date2020-07-10

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