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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 K863645
Device Name SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
Applicant
United Medical Systems, Inc.
1901 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact GABRIEL DEUTSCH
Correspondent
United Medical Systems, Inc.
1901 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact GABRIEL DEUTSCH
Regulation Number884.4530
Classification Product Code
HFW  
Date Received09/18/1986
Decision Date 09/25/1986
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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