510(k) K062544 ยท LFL Instrument, Ultrasonic Surgical
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
| Applicant | Arobella Medical, LLC, Carmel IN, US |
| Decision | Substantially Equivalent, Jan 3, 2007 |
| Received | Aug 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2012 | Arobella Medical, LLC Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System.
Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, do Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.