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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 K013536
Device Name EMTRAC; DELPHIN; SEMTRAC 2000 SET
Applicant
Gynetics Medical Products NV
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Gynetics Medical Products NV
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6110
Classification Product Code
MQF  
Date Received10/23/2001
Decision Date 11/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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