The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Voyant Electrosurgical Generator, Voyant 5mm Laparoscopic Sealer-divider Device.
| Device ID | K141288 |
| 510k Number | K141288 |
| Device Name: | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Jessica Cho |
| Correspondent | Jessica Cho APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-16 |
| Decision Date | 2014-08-22 |
| Summary: | summary |