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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
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