The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Vfs1 Bipolar Electrosurgical Generator.
| Device ID | K200169 |
| 510k Number | K200169 |
| Device Name: | VFS1 Bipolar Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | FHC, Inc. 1201 Main Street Bowdoin, ME 04287 |
| Contact | Kelly Moeykens |
| Correspondent | Craig Pagan C2C Development, LLC 1135 W NASA Blvd, Suite 500 Melbourne, FL 32901 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-23 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00873263008164 | K200169 | 000 |
| 00873263008157 | K200169 | 000 |