The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Caiman 5 Maryland.
Device ID | K183180 |
510k Number | K183180 |
Device Name: | Caiman 5 Maryland |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Jessica Stigliano |
Correspondent | Jessica Stigliano Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-19 |
Decision Date | 2019-03-12 |