Device Classification Name |
Stapler, Surgical
|
510(k) Number |
K803038 |
Device Name |
PROXIMATE*II DISPOSABLE SKIN STAPLER |
Applicant |
ETHICON, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ETHICON, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4740
|
Classification Product Code |
|
Date Received | 12/01/1980 |
Decision Date | 12/30/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|