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FDA 510(k) Application Details - K140768
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K140768
Device Name
Introducer, Catheter
Applicant
LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD.
1531 FELTON ROAD
SOUTH EUCLID, OH 44121 US
Other 510(k) Applications for this Company
Contact
ARTHUR GODDARD
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
03/27/2014
Decision Date
11/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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