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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 K951484
Device Name WESTMED BACTERIAL/VIRAL FILTER
Applicant
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Applicant Contact LYNN HAYSE
Correspondent
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Correspondent Contact LYNN HAYSE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/30/1995
Decision Date 04/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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