Device Classification Name |
staple, implantable
|
510(k) Number |
K051002 |
FOIA Releasable 510(k) |
K051002
|
Device Name |
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
GEORGIA C ABERNATHY |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
GEORGIA C ABERNATHY |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 04/20/2005 |
Decision Date | 05/17/2005 |
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
|
Recalls |
CDRH Recalls
|
|
|