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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 K023379
Device Name COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
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 12/11/2002
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
Predetermined Change
Control Plan Authorized		 No
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