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FDA 510(k) Application Details - K053229
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K053229
Device Name
Generator, Oxygen, Portable
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG 407 TW
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Contact
STEVE CHAO
Other 510(k) Applications for this Contact
Regulation Number
868.5440
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Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
11/18/2005
Decision Date
03/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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