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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K910246
Device Name CORE DISPOSABLE SUCTION/IRRIGATION TUBING
Applicant
Core Dynamics, Inc.
9951 Atlantic Blvd.
Suite 318
Jacksonville,  FL  32225
Applicant Contact TIM REIS
Correspondent
Core Dynamics, Inc.
9951 Atlantic Blvd.
Suite 318
Jacksonville,  FL  32225
Correspondent Contact TIM REIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/22/1991
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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