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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intrauterine And Introducer
510(k) Number K905812
Device Name INTRAUTERINE CATHETER SET
Applicant
Epcom Medical Systems, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Applicant Contact CHERYL KUTCHERA
Correspondent
Epcom Medical Systems, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Correspondent Contact CHERYL KUTCHERA
Regulation Number884.2700
Classification Product Code
HGS  
Date Received12/28/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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