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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 K002838
Device Name GASTRIC SUCTION AND DRAINAGE CATHETER
Applicant
BIOENTERICS CORP.
1035 CINDY LN.
CARPINTERIA,  CA  93013
Applicant Contact DAVID MUNJAL
Correspondent
BIOENTERICS CORP.
1035 CINDY LN.
CARPINTERIA,  CA  93013
Correspondent Contact DAVID MUNJAL
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/12/2000
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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