The following data is part of a premarket notification filed by Adeor Medical Technologies Gmbh with the FDA for Meridian Cranial Perforator.
| Device ID | K121253 |
| 510k Number | K121253 |
| Device Name: | MERIDIAN CRANIAL PERFORATOR |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | ADEOR MEDICAL TECHNOLOGIES GMBH KIRCHPLATZ 1 Pullach, DE 82049 |
| Contact | Fabio Von Zeppelin |
| Correspondent | Fabio Von Zeppelin ADEOR MEDICAL TECHNOLOGIES GMBH KIRCHPLATZ 1 Pullach, DE 82049 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-25 |
| Decision Date | 2012-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EADEPERC811S1 | K121253 | 000 |
| EADEPERC69S1 | K121253 | 000 |
| EADEPERC1114S1 | K121253 | 000 |
| EADEPER711SP1 | K121253 | 000 |
| EADEPER711S1 | K121253 | 000 |
| EADEPER1114SP1 | K121253 | 000 |
| EADEPER1114SG1 | K121253 | 000 |
| EADEPER1114S1 | K121253 | 000 |