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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 K003703
Device Name TAUT-INSUFFLATION NEEDLE
Applicant
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Applicant Contact RONALD KENSETH
Correspondent
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Correspondent Contact RONALD KENSETH
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/01/2000
Decision Date 02/22/2001
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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