Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K112642 |
Device Name |
AQUILEX FLUID CONTROL SYSTEM H112 |
Applicant |
W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
SUSANNE RAAB |
Correspondent |
W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 09/12/2011 |
Decision Date | 02/06/2012 |
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
|
|
|