Device Classification Name |
cannula, surgical, general & plastic surgery
|
510(k) Number |
K920110 |
Device Name |
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE |
Applicant |
ETHICON, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
SANDRA DIGGS |
Correspondent |
ETHICON, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
SANDRA DIGGS |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/07/1992 |
Decision Date | 04/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|