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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K923439
Device Name LUNEAU UMBILICAL CORD CLAMP
Applicant
Laboratoires Luneau
B.P 252
28005 Chartres Cedex
France,  FR
Applicant Contact YOUNG
Correspondent
Laboratoires Luneau
B.P 252
28005 Chartres Cedex
France,  FR
Correspondent Contact YOUNG
Regulation Number884.4530
Classification Product Code
HFW  
Date Received07/13/1992
Decision Date 05/21/1993
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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