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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 K953611
Device Name DEXIDE ENDO-LUBE KIT
Applicant
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Applicant Contact ROGER COOPER
Correspondent
DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH,  TX  76118
Correspondent Contact ROGER COOPER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/02/1995
Decision Date 09/15/1995
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
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