The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Yasargil Fenestrated Aneurysm Clip &.
Device ID | K833652 |
510k Number | K833652 |
Device Name: | YASARGIL FENESTRATED ANEURYSM CLIP & |
Classification | Clip, Aneurysm |
Applicant | ADVANCED BIOSEARCH ASSN. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-19 |
Decision Date | 1984-01-27 |