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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 K033846
Device Name KAEN YIH UMBILICAL CORD CLAMP
Applicant
Kaen Yih Enterprise Co., Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact ANTONIO L GIACCIO
Correspondent
Kaen Yih Enterprise Co., Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact ANTONIO L GIACCIO
Regulation Number884.4530
Classification Product Code
HFW  
Date Received12/11/2003
Decision Date 03/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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