Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K061050 |
Device Name |
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R |
Applicant |
ETHICON, INC. |
P.O. BOX 151 |
ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
BRYAN LISA |
Correspondent |
ETHICON, INC. |
P.O. BOX 151 |
ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
BRYAN LISA |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 04/17/2006 |
Decision Date | 07/14/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|