CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C


Device Classification Name

hysteroscope (and accessories)

510(k) Number K991563
Device Name CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
Applicant
HENKE SASS WOLF OF AMERICA, INC.
73 eagles nest rd.
duxbury, 
MA 
02332

Applicant Contact ellen henke
Correspondent
HENKE SASS WOLF OF AMERICA, INC.
73 eagles nest rd.
duxbury, 
MA 
02332

Correspodent Contact ellen henke
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 05/05/1999
Decision Date 10/13/1999
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