The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Caiman Seal And Cut Technology.
Device ID | K151858 |
510k Number | K151858 |
Device Name: | Caiman Seal And Cut Technology |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Denise Adams |
Correspondent | Denise Adams 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 | 2015-07-08 |
Decision Date | 2015-07-21 |
Summary: | summary |