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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K924117
Device Name DEXIDE LAPAROSCOPIC KITS
Applicant
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Applicant Contact KEITH JUNG
Correspondent
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Correspondent Contact KEITH JUNG
Regulation Number878.4800
Classification Product Code
KDD  
Date Received08/14/1992
Decision Date 03/23/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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