Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K091010 |
Device Name |
TROKAMED MORCELLATOR |
Applicant |
TROKAMED GMBH |
AMSTEL 320-I |
AMSTERDAM,
NL
1017AP
|
|
Applicant Contact |
ANGELIKA SCHERP |
Correspondent |
TROKAMED GMBH |
AMSTEL 320-I |
AMSTERDAM,
NL
1017AP
|
|
Correspondent Contact |
ANGELIKA SCHERP |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 04/09/2009 |
Decision Date | 03/01/2011 |
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
|
|
|