510(k) K052415 ยท GDW Staple, Implantable
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
| Applicant | Power Medical Interventions, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Sep 29, 2005 |
| Received | Sep 2, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2007 | Power Medical Interventions, Inc Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60 Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.