The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Ultrasonic Curved Shears With Torque Wrench And Grip Assist Model Fcs9, Twblue, Gablue.
| Device ID | K100537 |
| 510k Number | K100537 |
| Device Name: | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE |
| Classification | Scalpel, Ultrasonic, 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 | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825016013 | K100537 | 000 |