DEXIDE LAPAROSCOPIC KITS

Kit, Surgical Instrument, Disposable

DEXIDE, INC.

The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Laparoscopic Kits.

Pre-market Notification Details

Device IDK924117
510k NumberK924117
Device Name:DEXIDE LAPAROSCOPIC KITS
ClassificationKit, Surgical Instrument, Disposable
Applicant DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth,  TX  76118
ContactKeith Jung
CorrespondentKeith Jung
DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth,  TX  76118
Product CodeKDD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-14
Decision Date1993-03-23

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