PETIT SOPHIA


Device Classification Name

device, fertility diagnostic, proceptive

510(k) Number K021978
Device Name PETIT SOPHIA
Original Applicant
NISHITOMO CO., INC.
3696 west main st.
gray, 
LA 
70359

Original Contact lloyd duplantis
Classification Product Code
LHD  
Date Received 06/17/2002
Decision Date 04/08/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No