The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Ultrasonic Coagulating Shears.
| Device ID | K093702 |
| 510k Number | K093702 |
| Device Name: | REPROCESSED ULTRASONIC COAGULATING SHEARS |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton Varty |
| Correspondent | Moira Barton Varty ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825015788 | K093702 | 000 |