The following data is part of a premarket notification filed by Rebstock - Instrumente Gmbh with the FDA for Rebstock Yasargil Aneurysm Clip.
Device ID | K003500 |
510k Number | K003500 |
Device Name: | REBSTOCK YASARGIL ANEURYSM CLIP |
Classification | Clip, Aneurysm |
Applicant | REBSTOCK - INSTRUMENTE GMBH IN BREITEN 12 Duerbheim, DE 78589 |
Contact | Dieter Rebstock |
Correspondent | Dieter Rebstock REBSTOCK - INSTRUMENTE GMBH IN BREITEN 12 Duerbheim, DE 78589 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-13 |
Decision Date | 2001-05-30 |