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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 K901407
Device Name CORE DISPOSABLE TROCARS
Applicant
Core Dynamics, Inc.
P.O. Box 16351
Jacksonville,  FL  32245
Applicant Contact TIM REIS
Correspondent
Core Dynamics, Inc.
P.O. Box 16351
Jacksonville,  FL  32245
Correspondent Contact TIM REIS
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/26/1990
Decision Date 06/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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