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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K862448
Device Name FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
Applicant
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Applicant Contact GILBERT KIRK
Correspondent
LIFE DESIGN SYSTEMS, INC.
11017 WEST LAYTON AVE.
MILWAUKEE,  WI  53228
Correspondent Contact GILBERT KIRK
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/27/1986
Decision Date 11/14/1986
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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