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FDA 510(k) Application Details - K013093
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K013093
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
PALL MEDICAL
600 S. WAGNER RD.
ANN ARBOR, MI 48103 US
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Contact
LEONARD S BERMAN
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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
09/17/2001
Decision Date
08/01/2002
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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