Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K010870 |
Device Name |
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
DENNIS HAHN |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
DENNIS HAHN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/23/2001 |
Decision Date | 06/18/2001 |
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
|
|
|