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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 K011621
Device Name KOALA CLAMP, KOALA CLAMP AND CUTTER
Applicant
MATERNUS, INC.
P.O. BOX 782089
SAN ANTONIO,  TX  78278
Applicant Contact RONALD B HICKS
Correspondent
MATERNUS, INC.
P.O. BOX 782089
SAN ANTONIO,  TX  78278
Correspondent Contact RONALD B HICKS
Regulation Number884.4530
Classification Product Code
HFW  
Date Received05/25/2001
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
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