FDA 510(k) Application Details - K210674

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K210674
Device Name Stimulator, Muscle, Powered
Applicant NCS Lab Srl
Via Pola Esterna 4/12
Carpi 41012 IT
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Contact Matteo Mantovani
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/05/2021
Decision Date 08/24/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K210674


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