FDA 510(k) Application Details - K060392

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K060392
Device Name Needle, Acupuncture, Single Use
Applicant SEDATELEC
13 RED FOX LANE
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 02/15/2006
Decision Date 04/26/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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