The following data is part of a premarket notification filed by Peter Lazic Gmbh with the FDA for D-clip; D-clip Applier.
| Device ID | K180757 |
| 510k Number | K180757 |
| Device Name: | D-Clip; D-Clip Applier |
| Classification | Clip, Aneurysm |
| Applicant | Peter Lazic GmbH Immelmannweg 2 Tuttlingen, DE 78532 |
| Contact | Sven Lazic |
| Correspondent | Sven Lazic Peter Lazic GmbH Immelmannweg 2 Tuttlingen, DE 78532 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2019-04-12 |