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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 K895360
Device Name C.P.A.P. VALVE AND C.P.P.A. KIT
Applicant
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact CHAMBERLAIN JR
Correspondent
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact CHAMBERLAIN JR
Regulation Number868.5965
Classification Product Code
BYE  
Date Received08/28/1989
Decision Date 11/15/1989
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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