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FDA 510(k) Application Details - K200496
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K200496
Device Name
Generator, Oxygen, Portable
Applicant
3B Medical Inc.
203 Avenue A NW, Suite 300
Winter Haven, FL 33881 US
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Contact
Yasser Estafanous
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
02/28/2020
Decision Date
07/24/2020
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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