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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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