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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 K010835
Device Name POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Applicant Contact VICKI ATOR
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Correspondent Contact VICKI ATOR
Regulation Number884.4530
Classification Product Code
HFW  
Date Received03/20/2001
Decision Date 04/30/2001
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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