The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Medicon Titanium Yasargil Aneurysm Clips.
| Device ID | K010908 |
| 510k Number | K010908 |
| Device Name: | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS |
| Classification | Clip, Aneurysm |
| 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 | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-08-01 |