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FDA 510(k) Application Details - K051711
Device Classification Name
More FDA Info for this Device
510(K) Number
K051711
Device Name
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
Applicant
DENVER BIOMEDICAL, INC.
433 PARK POINT DR. SUITE 140
GOLDEN, CO 80401 US
Other 510(k) Applications for this Company
Contact
NANCY SAUER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2005
Decision Date
11/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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