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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Uterine
510(k) Number K011840
Device Name CERVILENZ UTERINE MEASURING SOUND
Applicant
Cervilenz, Inc.
2 Delphinus
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Cervilenz, Inc.
2 Delphinus
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number884.4530
Classification Product Code
HHM  
Date Received06/12/2001
Decision Date 08/10/2001
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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