The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Slim Clip Applier Forceps.
Device ID | K173271 |
510k Number | K173271 |
Device Name: | Aesculap Slim Clip Applier Forceps |
Classification | Applier, Aneurysm Clip |
Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Paul Amudala |
Correspondent | Paul Amudala Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | HCI |
CFR Regulation Number | 882.4175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-12 |
Decision Date | 2017-11-10 |
Summary: | summary |