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FDA 510(k) Application Details - K093637
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K093637
Device Name
Needle, Fistula
Applicant
JMS NORTH AMERICA CORP.
1468 HARWELL AVE
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E J SMITH
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
FIE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2009
Decision Date
02/09/2010
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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