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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 K854458
Device Name CUSHION-FLEX TM-CPAP FACE MASK
Applicant
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Applicant Contact GILBERT M KIRK
Correspondent
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Correspondent Contact GILBERT M KIRK
Regulation Number868.5965
Classification Product Code
BYE  
Date Received11/06/1985
Decision Date 01/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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