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FDA 510(k) Application Details - K033936
Device Classification Name
Dilator, Esophageal
More FDA Info for this Device
510(K) Number
K033936
Device Name
Dilator, Esophageal
Applicant
C.R. BARD, INC.
129 CONCORD ROAD
BUILDING 3
BILLERICA, MA 01821 US
Other 510(k) Applications for this Company
Contact
MICHAEL A PATZ
Other 510(k) Applications for this Contact
Regulation Number
876.5365
More FDA Info for this Regulation Number
Classification Product Code
KNQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2003
Decision Date
01/14/2004
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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