HYSTEREOSCOPY PUMP HM4


Device Classification Name

insufflator, hysteroscopic

510(k) Number K022449
Device Name HYSTEREOSCOPY PUMP HM4
Original Applicant
W.O.M. WORLD OF MEDICINE AG
91 trowbridge st.
cambridge, 
MA 
02138

Original Contact susanne raab
Regulation Number 884.1700
Classification Product Code
HIG  
Date Received 07/26/2002
Decision Date 04/10/2003
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