Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K172040 |
Device Name |
Aquilex Fluid Control System AQL-100S |
Applicant |
W.O.M. World Of Medicine GmbH |
Salzufer 8 |
Berlin,
DE
10587
|
|
Applicant Contact |
Lucia Puetmann |
Correspondent |
Susanne Raab |
Guenthersburgallee 75 |
Frankfurt,
DE
60389
|
|
Correspondent Contact |
Susanne Raab |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 07/05/2017 |
Decision Date | 02/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|