The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Hand Activate Sealer/divider.
| Device ID | K111600 |
| 510k Number | K111600 |
| Device Name: | REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Ramona Kulik |
| Correspondent | Ramona Kulik ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-08 |
| Decision Date | 2011-11-15 |
| Summary: | summary |