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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 K953687
Device Name WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER
Applicant
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Applicant Contact LYNN D HAYSE
Correspondent
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Correspondent Contact LYNN D HAYSE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/07/1995
Decision Date 09/18/1995
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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