FDA 510(k) Application Details - K150903

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K150903
Device Name Needle, Acupuncture, Single Use
Applicant MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
1358 Meishan Road, Economic & Technology Development Zone
Maanshan 243041 CN
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Contact Viva Gu
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 04/03/2015
Decision Date 07/15/2015
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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