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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K192715
Device Name CRF Radiofrequency Ablation System
Applicant
Cambridge Interventional LLC
78 Cambridge Street
Burlington,  MA  01803
Applicant Contact Michael A. Arnold
Correspondent
Cambridge Interventional LLC
78 Cambridge Street
Burlington,  MA  01803
Correspondent Contact Michael A. Arnold
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/27/2019
Decision Date 01/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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