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FDA 510(k) Application Details - K111948
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K111948
Device Name
Needle, Fistula
Applicant
JMS NORTH AMERICA CORPORATION
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
07/08/2011
Decision Date
10/24/2011
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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