The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Fixit Headrest Clamp System.
| Device ID | K083803 |
| 510k Number | K083803 |
| Device Name: | FIXIT HEADREST CLAMP SYSTEM |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Contact | Joachim Schmid |
| Correspondent | Joachim Schmid MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2010-03-10 |
| Summary: | summary |