FDA 510(k) Application Details - K031716

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K031716
Device Name Needle, Acupuncture, Single Use
Applicant ASIA-MED GMBH AND CO KG
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact Kevin Walls
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 06/03/2003
Decision Date 07/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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