FDA 510(k) Application Details - K090910

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K090910
Device Name Needle, Acupuncture, Single Use
Applicant HANSOL MEDICAL CO.
300 ATWOOD ST.
PITTSBURGH, PA 15213 US
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Contact PETER CHUN
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 04/01/2009
Decision Date 06/30/2009
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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