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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 K010695
Device Name KOALA CLAMP
Applicant
MATERNUS, INC.
13223 HUNTERS LARK
SAN ANTONIO,  TX  78230
Applicant Contact RONALD B HICKS
Correspondent
MATERNUS, INC.
13223 HUNTERS LARK
SAN ANTONIO,  TX  78230
Correspondent Contact RONALD B HICKS
Regulation Number884.4530
Classification Product Code
HFW  
Date Received03/08/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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