FDA 510(k) Application Details - K002921

Device Classification Name Syringe, Piston

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510(K) Number K002921
Device Name Syringe, Piston
Applicant HOSUK CO., LTD.
52-6 DUKJEONG-RI, SAMSUNG-MYUN
UMSUNG-GUN, CHUNGCHEONG KR
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Contact Y. H KIM
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 09/19/2000
Decision Date 10/18/2000
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 Y
Expedited Review



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