FDA 510(k) Application Details - K052650

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K052650
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG 407 TW
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Contact STEVE CHAO
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 09/26/2005
Decision Date 11/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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