FDA 510(k) Application Details - K012501

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K012501
Device Name Needle, Acupuncture, Single Use
Applicant HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C.
1427 GREENBRIAR DR.
ALLEN, TX 75013 US
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Contact GEOFFREY HSU
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 08/03/2001
Decision Date 12/11/2001
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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