Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K912492 |
Device Name |
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
JOHN D PAULSON |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
JOHN D PAULSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/04/1991 |
Decision Date | 10/21/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|