SYDNEY IVF CULTURE OIL


Device Classification Name

media, reproductive

510(k) Number K022002
Device Name SYDNEY IVF CULTURE OIL
Original Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
p.o. box 227
spencer, 
IN 
47460

Original Contact brenda davis
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 06/19/2002
Decision Date 08/12/2002
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

Recalls CDRH Recalls