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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 K901557
Device Name UMBILICAL CORD CLAMP AND CUTTER
Applicant
Microtek-Heritage, Inc.
P.O. Box 1147
Tucker,  GA  30085
Applicant Contact A SMALLWOOD
Correspondent
Microtek-Heritage, Inc.
P.O. Box 1147
Tucker,  GA  30085
Correspondent Contact A SMALLWOOD
Regulation Number884.4530
Classification Product Code
HFW  
Date Received04/03/1990
Decision Date 05/15/1990
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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