FDA 510(k) Application Details - K000740

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K000740
Device Name Needle, Acupuncture, Single Use
Applicant ASAHI IRYOKI CO. LTD
10 NEW KING ST.
SUITE 106
WHITE PLAINS, NY 10604 US
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Contact MIKE PAWLUK
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 03/07/2000
Decision Date 04/12/2000
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 N
Expedited Review



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