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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pneumoperitoneum needle
510(k) Number K914426
Device Name ENTREE NEEDLE
Applicant
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Applicant Contact TIM REIS
Correspondent
CORE DYNAMICS, INC.
11222-4 ST. JOHNS
INDUSTRIAL PARKWAY
JACKSONVILLE,  FL  32246
Correspondent Contact TIM REIS
Regulation Number876.1500
Classification Product Code
FHO  
Date Received10/02/1991
Decision Date 11/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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