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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 K961914
Device Name BACTERIA/VIRAL FILTER
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589
Applicant Contact ARDEN MORLEY
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589
Correspondent Contact ARDEN MORLEY
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/17/1996
Decision Date 08/14/1996
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
Predetermined Change
Control Plan Authorized		 No
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