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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 K880753
Device Name UMBILICAL CORD CLAMP
Applicant
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Applicant Contact BERNARD E LADERMAN
Correspondent
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Correspondent Contact BERNARD E LADERMAN
Regulation Number884.4530
Classification Product Code
HFW  
Date Received02/25/1988
Decision Date 04/27/1988
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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