UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753

Device Classification Name

hysteroscope (and accessories)

510(k) Number K033113
Device Name UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills, 
IL 
60061

Applicant Contact robert l casarsa
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills, 
IL 
60061

Correspodent Contact robert l casarsa
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 09/30/2003
Decision Date 12/23/2003
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