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FDA 510(k) Application Details - K141025
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
More FDA Info for this Device
510(K) Number
K141025
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
BROSMED MEDICAL
15TH-BUILDING,SMES VENTURE PARK,SONGSHAN LAKE HI-TECH
DEVELOPMENT ZONE
DONGGUAN, GUANGDONG 523808 CN
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Contact
STEPHEN LEE
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2014
Decision Date
09/12/2014
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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