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FDA 510(k) Application Details - K965020
Device Classification Name
Filter, Bacterial, Breathing-Circuit
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510(K) Number
K965020
Device Name
Filter, Bacterial, Breathing-Circuit
Applicant
POROUS MEDIA CORP.
1350 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
KEITH A ROBERTS
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Regulation Number
868.5260
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Classification Product Code
CAH
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Date Received
12/16/1996
Decision Date
03/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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