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FDA 510(k) Application Details - K100184
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K100184
Device Name
Catheter, Percutaneous
Applicant
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
# 19, LN 999, ZHONGSHAN RD S2
SUITE 5D
SHANGHAI 200030 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
01/21/2010
Decision Date
02/14/2011
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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