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FDA 510(k) Application Details - K003451
Device Classification Name
Shunt, Peritoneal
More FDA Info for this Device
510(K) Number
K003451
Device Name
Shunt, Peritoneal
Applicant
DENVER BIOMEDICALS, INC.
14998 W. 6TH AVE., BLDG. E700
GOLDEN, CO 80401 US
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Contact
BONNIE VIVIAN
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Regulation Number
876.5955
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Classification Product Code
KPM
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More FDA Info for this Product Code
Date Received
11/07/2000
Decision Date
01/02/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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