The following data is part of a premarket notification filed by Von Zeppelin Gmbh with the FDA for Perneczky Clip Applier/remover.
| Device ID | K954658 |
| 510k Number | K954658 |
| Device Name: | PERNECZKY CLIP APPLIER/REMOVER |
| Classification | Applier, Aneurysm Clip |
| Applicant | VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
| Contact | Dieter Von Zeppelin |
| Correspondent | Dieter Von Zeppelin VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-10-08 |