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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 K912869
Device Name WOMEN AND INFANT'S DELIVERY PACK
Applicant
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Applicant Contact RICHARD P WELCH
Correspondent
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Correspondent Contact RICHARD P WELCH
Regulation Number884.4530
Classification Product Code
HFW  
Date Received06/28/1991
Decision Date 12/04/1991
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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