| Device Classification Name |
laparoscope, gynecologic (and accessories)
|
|---|
| 510(k) Number |
K993801 |
|---|
| Device Name |
GYNECARE LAPAROSCOPIC MORCELLATOR |
|---|
| Applicant |
| ETHICON, INC. |
| ROUTE 22 WEST |
| P.O. BOX 151 |
|
SOMERVILLE,
NJ
08876 -0151
|
|
| Applicant Contact |
GREGORY R JONES |
| Correspondent |
| ETHICON, INC. |
| ROUTE 22 WEST |
| P.O. BOX 151 |
|
SOMERVILLE,
NJ
08876 -0151
|
|
| Correspondent Contact |
GREGORY R JONES |
| Regulation Number | 884.1720
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/09/1999 |
|---|
| Decision Date | 02/07/2000 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
|---|
| 510k Review Panel |
Obstetrics/Gynecology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|