Gold Anchor

Accelerator, Linear, Medical

Naslund Medical AB

The following data is part of a premarket notification filed by Naslund Medical Ab with the FDA for Gold Anchor.

Pre-market Notification Details

Device IDK201117
510k NumberK201117
Device Name:Gold Anchor
ClassificationAccelerator, Linear, Medical
Applicant Naslund Medical AB Avagen 40 B Huddinge,  SE 14130
ContactTomas Naslund
CorrespondentTomas Naslund
Naslund Medical AB Avagen 40 B Huddinge,  SE 14130
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2020-06-11

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