510(k) K030318 ยท ELW Material, Impression
P2 POLYETHER
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Apr 3, 2003 |
| Received | Jan 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. Terminated |
ELW | None listed |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. Terminated |
ELW | None listed |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584. Terminated |
ELW | None listed |
| Mar 15, 2005 | Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582. Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.