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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 K990379
Device Name MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
Applicant
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Applicant Contact JOHN CORZINE
Correspondent
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Correspondent Contact JOHN CORZINE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/08/1999
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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