Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K151858 |
Device Name |
Caiman Seal and Cut Technology |
Applicant |
Aesculap, Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
Denise Adams |
Correspondent |
Aesculap, Inc. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
Denise Adams |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/08/2015 |
Decision Date | 07/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|