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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 K870446
Device Name DOLPHIN UMBILICAL CORD CLAMP
Applicant
Andermac, Inc.
2626 Live Oak Hwy.
Yuba City,  CA  95991
Applicant Contact HILLARD T WITT
Correspondent
Andermac, Inc.
2626 Live Oak Hwy.
Yuba City,  CA  95991
Correspondent Contact HILLARD T WITT
Regulation Number884.4530
Classification Product Code
HFW  
Date Received02/03/1987
Decision Date 02/17/1987
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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