The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr Arctic Suction Electrode.
Device ID | K140896 |
510k Number | K140896 |
Device Name: | VAPR ARCTIC SUCTION ELECTRODE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Susan Kagan |
Correspondent | Susan Kagan DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-08 |
Decision Date | 2014-08-05 |
Summary: | summary |