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FDA 510(k) Application Details - K201794
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K201794
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1st Jinkui Road Futian Free Trade Zone
Shenzhen 518038 CN
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Contact
Daniel Zhang
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2020
Decision Date
07/28/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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