Device Classification Name |
instrument, ultrasonic surgical
|
510(k) Number |
K151136 |
Device Name |
HARMONIC HOOK |
Applicant |
ETHICON ENDO-SURGERY, LLC |
475 CALLE C |
GUAYNABO,
PR
00969
|
|
Applicant Contact |
MARJORIE MEDINA |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
BRIAN GODWIN |
Classification Product Code |
|
Date Received | 04/29/2015 |
Decision Date | 03/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|