The following data is part of a premarket notification filed by Doceram Medical Ceramics Gmbh with the FDA for Nacera Z And Nacera Z Medium.
| Device ID | K080195 |
| 510k Number | K080195 |
| Device Name: | NACERA Z AND NACERA Z MEDIUM |
| Classification | Powder, Porcelain |
| Applicant | DOCERAM MEDICAL CERAMICS GMBH 65-67 HESSLINGSWEG Dortmund, Nrw, DE D-44309 |
| Contact | Holger Wampers |
| Correspondent | Holger Wampers DOCERAM MEDICAL CERAMICS GMBH 65-67 HESSLINGSWEG Dortmund, Nrw, DE D-44309 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMC34923000470 | K080195 | 000 |
| EDMC3293WN30950 | K080195 | 000 |
| EDMC3293WN30940 | K080195 | 000 |
| EDMC3292WN30990 | K080195 | 000 |
| EDMC3292WN30950 | K080195 | 000 |
| EDMC3292WN30940 | K080195 | 000 |
| EDMC3291WN30990 | K080195 | 000 |
| EDMC3291WN30950 | K080195 | 000 |
| EDMC3291WN30940 | K080195 | 000 |
| EDMC32923000050 | K080195 | 000 |
| EDMC32923000040 | K080195 | 000 |
| EDMC3293WN30990 | K080195 | 000 |
| EDMC34903000590 | K080195 | 000 |
| EDMC34923000460 | K080195 | 000 |
| EDMC34923000450 | K080195 | 000 |
| EDMC34923000440 | K080195 | 000 |
| EDMC34913000630 | K080195 | 000 |
| EDMC34913000620 | K080195 | 000 |
| EDMC34913000610 | K080195 | 000 |
| EDMC34913000600 | K080195 | 000 |
| EDMC34903000620 | K080195 | 000 |
| EDMC34903000610 | K080195 | 000 |
| EDMC34903000600 | K080195 | 000 |
| EDMC32923000030 | K080195 | 000 |