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FDA 510(k) Application Details - K051767
Device Classification Name
Ventilator, Continuous, Facility Use
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510(K) Number
K051767
Device Name
Ventilator, Continuous, Facility Use
Applicant
PULMONETIC SYSTEMS, INC.
17400 MEDINA ROAD
SUITE 100
MINNEAPOLIS, MN 55447 US
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Contact
ROBERT C SAMEC
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Regulation Number
868.5895
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Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
06/30/2005
Decision Date
07/29/2005
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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