NP1 Instrument, Creo Electrosurgical System

System, Ablation, Microwave And Accessories

Creo Medical Ltd.

The following data is part of a premarket notification filed by Creo Medical Ltd. with the FDA for Np1 Instrument, Creo Electrosurgical System.

Pre-market Notification Details

Device IDK200003
510k NumberK200003
Device Name:NP1 Instrument, Creo Electrosurgical System
ClassificationSystem, Ablation, Microwave And Accessories
Applicant Creo Medical Ltd. Creo House, Unit 2, Beaufort Park Way Chepstow,  GB Np16 5uh
ContactShaun Preston
CorrespondentPhil Triolo
Phil Triolo And Associates LC 86 Skycrest Ln Salt Lake City,  UT  84108
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-02
Decision Date2020-10-28

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