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FDA 510(k) Application Details - K142564
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K142564
Device Name
Needle, Fistula
Applicant
JMS North America Corporation
22320 Foothill Blvd., Suite 350
Hayward, CA 94541 US
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Contact
Sho Hosoki
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
FIE
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More FDA Info for this Product Code
Date Received
09/11/2014
Decision Date
12/23/2014
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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