LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES


Device Classification Name

culdoscope (and accessories)

510(k) Number K111014
Device Name LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
Applicant
LSI SOLUTIONS, INC.
7796 victor-mendon rd.
new york, 
NY 
14564

Applicant Contact jude s sauer, m.d.
Correspondent
LSI SOLUTIONS, INC.
7796 victor-mendon rd.
new york, 
NY 
14564

Correspodent Contact jude s sauer, m.d.
Regulation Number 884.1640
Classification Product Code
HEW  
Subsequent Product Code
LKF  
Date Received 04/11/2011
Decision Date 07/13/2012
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