SYDNEY IVF HYALURONIDASE


Device Classification Name

media, reproductive

510(k) Number K023353
Device Name SYDNEY IVF HYALURONIDASE
Original Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
p.o. box 227
spencer, 
IN 
47460

Original Contact debbie schmitt
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 10/07/2002
Decision Date 12/20/2002
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