The following data is part of a premarket notification filed by Von Zeppelin Gmbh with the FDA for Perneczky Aneurysm Clip.
Device ID | K901312 |
510k Number | K901312 |
Device Name: | PERNECZKY ANEURYSM CLIP |
Classification | Clip, Aneurysm |
Applicant | VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
Contact | Von Zeppelin |
Correspondent | Von Zeppelin VON ZEPPELIN GMBH GISTLSTRASSE 99 Pullach, DE D-82049 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-20 |
Decision Date | 1990-08-17 |