FDA 510(k) Application Details - K150758

Device Classification Name Syringe, Piston

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510(K) Number K150758
Device Name Syringe, Piston
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 880.5860

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Classification Product Code FMF
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Date Received 03/23/2015
Decision Date 06/18/2015
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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