The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Electrosurgical Instrument.
| Device ID | K110189 |
| 510k Number | K110189 |
| Device Name: | REPROCESSED ELECTROSURGICAL INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST STREET Phoenix, AZ 85044 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST STREET 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 | 2011-01-24 |
| Decision Date | 2011-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825013289 | K110189 | 000 |