The following data is part of a premarket notification filed by Medagent, Inc with the FDA for Bissinger Monopolar Forceps And Cables.
Device ID | K143662 |
510k Number | K143662 |
Device Name: | Bissinger Monopolar Forceps And Cables |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MEDAGENT, INC 112 CORPORATE DRIVE, UNIT 1 Portsmouth, NH 03801 |
Contact | Franz Menean |
Correspondent | Franz Menean MEDAGENT, INC 112 CORPORATE DRIVE, UNIT 1 Portsmouth, NH 03801 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-23 |
Decision Date | 2015-03-12 |
Summary: | summary |