The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Ligasure Vessel Sealer/divider.
| Device ID | K062525 |
| 510k Number | K062525 |
| Device Name: | REPROCESSED LIGASURE VESSEL SEALER/DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton |
| Correspondent | Moira Barton ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2007-05-16 |
| Summary: | summary |