SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT


Device Classification Name

media, reproductive

510(k) Number K030441
Device Name SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
Applicant
COOK OB/GYN
1100 west morgan st.
p.o. box 271
spencer, 
IN 
47460

Applicant Contact brenda davis
Correspondent
COOK OB/GYN
1100 west morgan st.
p.o. box 271
spencer, 
IN 
47460

Correspodent Contact brenda davis
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 02/11/2003
Decision Date 08/29/2003
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

Yes