510(k) K061430 ยท FEB Accessories, Cleaning, For Endoscope
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
| Applicant | Custom Ultrasonics, Ivyland PA, US |
| Decision | Substantially Equivalent, Jan 12, 2007 |
| Received | May 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2007 | Custom Ultrasonics, Inc. 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.