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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K944509
Device Name DEXIDE INSUFFLATION TUBING WITH FILTER
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 Number884.1730
Classification Product Code
HIF  
Date Received09/15/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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