The following data is part of a premarket notification filed by Aesculap Inc. with the FDA for Aesculap Caiman 5 Seal And Cut Technology System.
Device ID | K202938 |
510k Number | K202938 |
Device Name: | Aesculap Caiman 5 Seal And Cut Technology System |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Omunique (nikki) Luke |
Correspondent | Omunique (nikki) Luke Aesculap Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2020-10-30 |