FDA 510(k) Application Details - K024207

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K024207
Device Name Needle, Acupuncture, Single Use
Applicant HELIO MEDICAL SUPPLIES, INC.
606 CHARCOT AVE.
SAN JOSE, CA 95131 US
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Contact ERIC CHENG
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 12/20/2002
Decision Date 04/14/2003
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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