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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K932020
Device Name ENTREE BLUNT TIP TROCAR AND ADAPTER
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 Number884.1720
Classification Product Code
HET  
Date Received04/23/1993
Decision Date 01/11/1994
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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