The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Side Effect With Hand Controls, Hook Electrode With Hand Controls, 2.3 Wedge Electrode With Hand Controls, S90 With Hand.
Device ID | K120095 |
510k Number | K120095 |
Device Name: | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND |
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 | 2012-01-12 |
Decision Date | 2012-04-06 |
Summary: | summary |