Device Classification Name |
staple, implantable
|
510(k) Number |
K080972 |
Device Name |
ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP |
Applicant |
ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD. |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
RUTH A WOOD |
Correspondent |
ETHICON ENDO-SUGERY, LLC |
4545 CREEK RD. |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
RUTH A WOOD |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 04/04/2008 |
Decision Date | 07/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|