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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K921127
Device Name PANDA NEEDLE CATHETER JEJUNOSTOMY KIT
Applicant
KNIGHT MEDICAL, INC.
320 CHARLES ST.
CAMBRIDGE,  MA  02141
Applicant Contact DAVID KREIDER
Correspondent
KNIGHT MEDICAL, INC.
320 CHARLES ST.
CAMBRIDGE,  MA  02141
Correspondent Contact DAVID KREIDER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/10/1992
Decision Date 01/04/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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