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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 K905549
Device Name THE DART
Applicant
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Applicant Contact KEITH JUNG
Correspondent
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Correspondent Contact KEITH JUNG
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/11/1990
Decision Date 02/19/1991
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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