COOPERSURGICAL MALLEABLE SYTLET


Device Classification Name

catheter, assisted reproduction

510(k) Number K023382
Device Name COOPERSURGICAL MALLEABLE SYTLET
Original Applicant
COOPER SURGICAL
p.o. box 2156
huntington, 
CT 
06484

Original Contact joseph m azary
Regulation Number 884.6110
Classification Product Code
MQF  
Date Received 10/08/2002
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