The following data is part of a premarket notification filed by Peter Lazic Gmbh with the FDA for L-aneurysm-clip System & L-aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil Aneurysm Clip Appliers.
| Device ID | K081489 |
| 510k Number | K081489 |
| Device Name: | L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS |
| Classification | Clip, Aneurysm |
| Applicant | PETER LAZIC GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean PETER LAZIC GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-28 |
| Decision Date | 2008-09-25 |
| Summary: | summary |