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FDA 510(k) Application Details - K110246
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K110246
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
QSERVE AMERICA, INC.
220 RIVER RD.
CLAREMONT, NH 03743-5647 US
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Contact
WILLIAM GREENROSE
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Regulation Number
868.5260
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Classification Product Code
CAH
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Date Received
01/27/2011
Decision Date
11/04/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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