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FDA 510(k) Application Details - K002838
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
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510(K) Number
K002838
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
BIOENTERICS CORP.
1035 CINDY LN.
CARPINTERIA, CA 93013 US
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Contact
DAVID MUNJAL
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Regulation Number
876.5980
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Classification Product Code
KNT
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More FDA Info for this Product Code
Date Received
09/12/2000
Decision Date
07/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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