FDA 510(k) Application Details - K063448

Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered

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510(K) Number K063448
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant EMG TECHNOLOGY CO., LTD.
4F-2, NO. 210, 38 RD.
TAICHUNG INDUSTRIAL PARK
SHITUEN CHIU, TAICHUNG 40768 TW
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Contact SALLY CHUANG
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Regulation Number 878.4780

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Classification Product Code JCX
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Date Received 11/15/2006
Decision Date 11/30/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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