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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 K021055
Device Name BUSSE UMBILICAL CORD CLAMP CUTTER
Applicant
Busse Hospital Disposables, Inc.
P.O. Box 2156
Huntington,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Busse Hospital Disposables, Inc.
P.O. Box 2156
Huntington,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number884.4530
Classification Product Code
HFW  
Date Received04/01/2002
Decision Date 04/29/2002
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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