TRANSVAGINAL ENDOSCOPY SET


Device Classification Name

culdoscope (and accessories)

510(k) Number K033728
Device Name TRANSVAGINAL ENDOSCOPY SET
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
5th floor
culver city, 
CA 
90230 -7600

Applicant Contact yvonne fernandez
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
5th floor
culver city, 
CA 
90230 -7600

Correspodent Contact yvonne fernandez
Regulation Number 884.1640
Classification Product Code
HEW  
Date Received 11/28/2003
Decision Date 02/27/2004
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