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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K955047
Device Name WESTMED CIRCULARIE PEP DEVICES
Applicant
WESTMED INTL.
3351 EAST HEMISPHERE LOOP
TUCSON,  AZ  85706
Applicant Contact LYNN D HAYSE
Correspondent
WESTMED INTL.
3351 EAST HEMISPHERE LOOP
TUCSON,  AZ  85706
Correspondent Contact LYNN D HAYSE
Regulation Number868.5965
Classification Product Code
BYE  
Date Received11/03/1995
Decision Date 03/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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