Device Classification Name |
staple, implantable
|
510(k) Number |
K092577 |
Device Name |
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
Abhilasha Mukherjee |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
Abhilasha Mukherjee |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/21/2009 |
Decision Date | 09/15/2009 |
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
|
|
|