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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, assisted reproduction
510(k) Number K023382
Device Name COOPERSURGICAL MALLEABLE SYTLET
Applicant
COOPER SURGICAL
P.O. BOX 2156
HUNTINGTON,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
COOPER SURGICAL
P.O. BOX 2156
HUNTINGTON,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number884.6110
Classification Product Code
MQF  
Date Received10/08/2002
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
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