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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, bacterial, breathing-circuit
510(k) Number K121382
Device Name WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
Original Applicant
WESTMED, INC.
5580 s. nogales highway
tucson,  AZ  85706
Original Contact r. john mckinnon
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/08/2012
Decision Date 12/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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