The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Yasargil Aneurysm Clip Phynox Booster Clip.
Device ID | K032198 |
510k Number | K032198 |
Device Name: | AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP |
Classification | Clip, Aneurysm |
Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Matthew M Hull |
Correspondent | Matthew M Hull AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-18 |
Decision Date | 2003-08-20 |
Summary: | summary |