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FDA 510(k) Application Details - K011020
Device Classification Name
Shunt, Peritoneal
More FDA Info for this Device
510(K) Number
K011020
Device Name
Shunt, Peritoneal
Applicant
DENVER BIOMEDICALS, INC.
401 SPRUCE ST.
LOUISVILLE, CO 80027 US
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Contact
NANCY SAUER
Other 510(k) Applications for this Contact
Regulation Number
876.5955
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Classification Product Code
KPM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2001
Decision Date
06/01/2001
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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