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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 K854822
Device Name LDS PEEP VALVE
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 Received12/03/1985
Decision Date 02/24/1986
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
Recalls CDRH Recalls
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