FDA 510(k) Application Details - K011248

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K011248
Device Name Needle, Acupuncture, Single Use
Applicant ACUSUPPLY, INC.
3801 NE 207TH ST., SUITE 501
AVENTURA, FL 33180 US
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Contact FERES DAGER
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 04/23/2001
Decision Date 10/29/2001
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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