510(k) K021989 ยท LFL Instrument, Ultrasonic Surgical
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
| Applicant | Integra Neurosciences, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 13, 2002 |
| Received | Jun 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2006 | Integra LifeSciences Corp. Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set. Terminated |
LFL | None listed |
| Nov 16, 2005 | Integra LifeSciences Corp. Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set. Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.