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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 K963223
Device Name EZ-CIRC
Applicant
PHYLLIS ADAMS, RN, NPC, MSN
27 LADY DIANA CIRCLE
MARLTON,  NJ  08053
Applicant Contact FREDERIC STEINBERG
Correspondent
PHYLLIS ADAMS, RN, NPC, MSN
27 LADY DIANA CIRCLE
MARLTON,  NJ  08053
Correspondent Contact FREDERIC STEINBERG
Regulation Number884.4530
Classification Product Code
HFW  
Date Received08/16/1996
Decision Date 04/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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