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FDA 510(k) Application Details - K131968
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K131968
Device Name
Generator, Oxygen, Portable
Applicant
LONGFIAN SCITECH CO., LTD.
6840 SW 45TH LN
UNIT 5
MIAMI, FL 33155 US
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Contact
JUN PENG
Other 510(k) Applications for this Contact
Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
06/28/2013
Decision Date
09/05/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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