The following data is part of a premarket notification filed by Cambridge Interventional Llc with the FDA for Crf Radiofrequency Ablation System.
Device ID | K192715 |
510k Number | K192715 |
Device Name: | CRF Radiofrequency Ablation System |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Cambridge Interventional LLC 78 Cambridge Street Burlington, MA 01803 |
Contact | Michael A. Arnold |
Correspondent | Michael A. Arnold Cambridge Interventional LLC 78 Cambridge Street Burlington, MA 01803 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-27 |
Decision Date | 2020-01-07 |