510(k) K040208 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
| Applicant | Tz Medical, Inc., Portland OR, US |
| Decision | Substantially Equivalent, May 11, 2004 |
| Received | Jan 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | TZ Medical, Inc. Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03
Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.