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FDA 510(k) Application Details - K222538
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K222538
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
Sino Medical Sciences Technology Inc.
TEDA Biopharm Research, #5, 4th Street, TEDA
Tianjin 300457 CN
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Contact
Jianhua Sun
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOX
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More FDA Info for this Product Code
Date Received
08/22/2022
Decision Date
12/21/2022
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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