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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 K861758
Device Name CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
Applicant
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Applicant Contact GILBERT M KIRK
Correspondent
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Correspondent Contact GILBERT M KIRK
Regulation Number868.5965
Classification Product Code
BYE  
Date Received05/06/1986
Decision Date 07/14/1986
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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