SYDNEY IVF EMBRYO BIOPSY MEDIUM


Device Classification Name

media, reproductive

510(k) Number K023850
Device Name SYDNEY IVF EMBRYO BIOPSY MEDIUM
Original Applicant
COOK OB/GYN
1100 west morgan st.
p.o. box 271
spencer, 
IN 
47460

Original Contact debbie schmitt
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 11/19/2002
Decision Date 01/22/2003
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