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FDA 510(k) Application Details - K170071
Device Classification Name
Rhinoanemometer (Measurement Of Nasal Decongestion)
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510(K) Number
K170071
Device Name
Rhinoanemometer (Measurement Of Nasal Decongestion)
Applicant
Sleep Group Solutions
2035 Harding Street, Suite 200
Hollywood, FL 33020 US
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Contact
Rani Ben-David
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Regulation Number
868.1800
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Classification Product Code
BXQ
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More FDA Info for this Product Code
Date Received
01/09/2017
Decision Date
11/09/2017
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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