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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 K915569
Device Name UMBILICAL CLAMP
Applicant
GAM INDUSTRIES, INC.
P.O. BOX 2226
PETERSBURG,  VA  23804 -1526
Applicant Contact GARY J.BEDEN
Correspondent
GAM INDUSTRIES, INC.
P.O. BOX 2226
PETERSBURG,  VA  23804 -1526
Correspondent Contact GARY J.BEDEN
Regulation Number884.4530
Classification Product Code
HFW  
Date Received12/12/1991
Decision Date 09/23/1992
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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