FDA 510(k) Application Details - K152323

Device Classification Name Set, Administration, Intravascular

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510(K) Number K152323
Device Name Set, Administration, Intravascular
Applicant JIANGYIN CAINA TECHNOLOGY CO., LTD
NO. 2, TAIFU ROAD, HUASHI TOWN
JIANGYIN 214421 CN
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Contact JUN LU
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 08/17/2015
Decision Date 12/14/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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