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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)]
Applicant
Westmed, Inc.
5580 S. NOGALES HIGHWAY
TUCSON,  AZ  85706
Applicant Contact R. JOHN MCKINNON
Correspondent
Westmed, Inc.
5580 S. NOGALES HIGHWAY
TUCSON,  AZ  85706
Correspondent Contact R. JOHN MCKINNON
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/08/2012
Decision Date 12/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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