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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 K010007
Device Name ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
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 Number876.1500
Classification Product Code
GCJ  
Date Received01/02/2001
Decision Date 02/22/2001
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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