Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K132522 |
Device Name |
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
DAVID LOCKE |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
DAVID LOCKE |
Classification Product Code |
|
Date Received | 08/12/2013 |
Decision Date | 12/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|