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FDA 510(k) Application Details - K001496
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K001496
Device Name
Needle, Fistula
Applicant
EXELINT INTERNATIONAL CO.
5840 W. CENTINELA AVE.
LOS ANGELES, CA 90231-3194 US
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Contact
ARMAND HAMID
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
05/15/2000
Decision Date
08/01/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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