FDA 510(k) Application Details - K071524

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K071524
Device Name Needle, Acupuncture, Single Use
Applicant TCM WORLD INC.
1512 PROSPECT AVE. UNIT D
SAN GABRIEL, CA 91776 US
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Contact YUWADEE IMTANAVANICH
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 06/04/2007
Decision Date 04/10/2008
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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