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FDA 510(k) Application Details - K160481
Device Classification Name
Continuous, Ventilator, Home Use
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510(K) Number
K160481
Device Name
Continuous, Ventilator, Home Use
Applicant
BREAS MEDICAL AB
FORETAGSVAGEN 1
MOLNLYCKE VASTRA GOTALANDS LAN 435 33 SE
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Contact
Albert Cefalo
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Regulation Number
868.5895
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Classification Product Code
NOU
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More FDA Info for this Product Code
Date Received
02/22/2016
Decision Date
11/09/2016
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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