The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Yasargil Permanent Aneurysm Clips.
Device ID | K003519 |
510k Number | K003519 |
Device Name: | YASARGIL PERMANENT ANEURYSM CLIPS |
Classification | Clip, Aneurysm |
Applicant | AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
Contact | Joyce Thomas |
Correspondent | Joyce Thomas AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-15 |
Decision Date | 2001-01-29 |