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FDA 510(k) Application Details - K102317
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K102317
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
SLEEPNET CORPORATION
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134-2958 US
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Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
08/16/2010
Decision Date
05/17/2011
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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