FDA 510(k) Application Details - K980899

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K980899
Device Name Needle, Acupuncture, Single Use
Applicant KENSHIN TRADING CORP.
1815 WEST 213TH ST., SUITE 180
TORRANCE, CA 90501 US
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Contact KUNIO SUZUKI
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 03/10/1998
Decision Date 06/11/1998
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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