510(k) K052626 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
SMARTSUCTION HARMONY DEVICE
| Applicant | Haemonetics Corp., Braintree MA, US |
| Decision | Substantially Equivalent, Oct 5, 2005 |
| Received | Sep 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2006 | Haemonetics Corporation SmartSuction Harmony Powered Suction Device
Model Number: HAR-E-115-US Terminated |
BTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.