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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K901413
Device Name CORE DISPOSABLE INSUFFLATION TUBING
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 Number884.1300
Classification Product Code
HES  
Date Received03/26/1990
Decision Date 09/24/1990
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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