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FDA 510(k) Application Details - K102483
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K102483
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
SUNSET HEALTHCARE SOLUTIONS, LLC
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
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Contact
Kevin Walls
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Regulation Number
868.5260
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Classification Product Code
CAH
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More FDA Info for this Product Code
Date Received
08/30/2010
Decision Date
09/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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