The following data is part of a premarket notification filed by Neuwave Medical, Inc with the FDA for Certus 140 Microwave Ablation System And Accessories, Model Certus 140.
Device ID | K100744 |
510k Number | K100744 |
Device Name: | CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 |
Classification | System, Ablation, Microwave And Accessories |
Applicant | NEUWAVE MEDICAL, INC 3529 ANDERSON STREET Madison, WI 53704 |
Contact | Daniel Kosednar |
Correspondent | Daniel Kosednar NEUWAVE MEDICAL, INC 3529 ANDERSON STREET Madison, WI 53704 |
Product Code | NEY |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-16 |
Decision Date | 2010-10-22 |
Summary: | summary |