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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 K912419
Device Name CORDGUARD BLOOD COLLECTION DEVICE
Applicant
O.B. Tech., Inc.
5842 Research Dr.
Huntington Beach,  CA  92649
Applicant Contact STEPHEN R HESSEL
Correspondent
O.B. Tech., Inc.
5842 Research Dr.
Huntington Beach,  CA  92649
Correspondent Contact STEPHEN R HESSEL
Regulation Number884.4530
Classification Product Code
HFW  
Date Received05/31/1991
Decision Date 10/05/1992
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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