510(k) K100537 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, May 12, 2010 |
| Received | Feb 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100537
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.