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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 K041332
Device Name JOEY CLAMP OPENING TOOL
Applicant
Maternus, Inc.
15303 Huebner Rd., Bldg. 10
San Antonio,  TX  78248
Applicant Contact RONALD B HICKS
Correspondent
Maternus, Inc.
15303 Huebner Rd., Bldg. 10
San Antonio,  TX  78248
Correspondent Contact RONALD B HICKS
Regulation Number884.4530
Classification Product Code
HFW  
Date Received05/19/2004
Decision Date 06/25/2004
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
Predetermined Change
Control Plan Authorized		 No
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