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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 K981941
Device Name MULTAPORT CANNULA REDUCER AND ACCESSORIES
Applicant
Dexide, Inc.
7509 Flagstone Dr.
Fort Worth,  TX  76118
Applicant Contact LYNETTE CALDWELL
Correspondent
Dexide, Inc.
7509 Flagstone Dr.
Fort Worth,  TX  76118
Correspondent Contact LYNETTE CALDWELL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/02/1998
Decision Date 07/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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