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FDA 510(k) Application Details - K021340
Device Classification Name
Device, Counter-Pulsating, External
More FDA Info for this Device
510(K) Number
K021340
Device Name
Device, Counter-Pulsating, External
Applicant
EXTERNAL COUNTERPULSATION LAB
85 WU JIN ROAD
SHANGHAI 200080 CN
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Contact
DAWEI CAI
Other 510(k) Applications for this Contact
Regulation Number
870.5225
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Classification Product Code
DRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2002
Decision Date
01/30/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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