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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 K894646
Device Name #556 DISPOSABLE UMBILICAL CORD CLAMP (2)
Applicant
Alpha Unlimited, Inc.
P.O. Box 808
701 N. Greenwood Ave.
Clearwater,  FL  33517
Applicant Contact BRENT MAGERS
Correspondent
Alpha Unlimited, Inc.
P.O. Box 808
701 N. Greenwood Ave.
Clearwater,  FL  33517
Correspondent Contact BRENT MAGERS
Regulation Number884.4530
Classification Product Code
HFW  
Date Received07/24/1989
Decision Date 09/05/1989
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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