AQUILEX FLUID CONTROL SYSTEM H112


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

Correspodent Contact susanne raab
Regulation Number 884.1700
Classification Product Code
HIG  
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