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510(k) K102483

SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 by Sunset Healthcare Solutions, LLC — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2011
Date Received
August 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

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