MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,


Device Classification Name

microtools, assisted reproduction (pipettes)

510(k) Number K033903
Device Name MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Applicant Contact brenda davis
Correspondent
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Correspodent Contact brenda davis
Regulation Number 884.6130
Classification Product Code
MQH  
Date Received 12/17/2003
Decision Date 01/16/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No