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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 K951140
Device Name KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
Applicant
Balagan Medical, Inc.
15611 Product Ln.
B-14
Huntington Beach,  CA  92649
Applicant Contact STEPHEN R HESSEL
Correspondent
Balagan Medical, Inc.
15611 Product Ln.
B-14
Huntington Beach,  CA  92649
Correspondent Contact STEPHEN R HESSEL
Regulation Number884.4530
Classification Product Code
HFW  
Date Received03/13/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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