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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 K960883
Device Name INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
Applicant
TAUT, INC.
2571 kaneville court
p.o. box 326
geneva,  IL  60134
Applicant Contact glenn miller
Correspondent
TAUT, INC.
2571 kaneville court
p.o. box 326
geneva,  IL  60134
Correspodent Contact glenn miller
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/05/1996
Decision Date 03/20/1996
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
Recalls CDRH Recalls
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