FDA 510(k) Application Details - K990328

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K990328
Device Name Needle, Acupuncture, Single Use
Applicant MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC.
1429 LYNDON ST.
SOUTH PASADENA, CA 91030 US
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Contact AE-HOE KWON
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 02/02/1999
Decision Date 05/04/1999
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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