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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 K904344
Device Name SLEEPER MASK SYSTEM
Applicant
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501 -0635
Applicant Contact DAVID GAST
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501 -0635
Correspondent Contact DAVID GAST
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/24/1990
Decision Date 05/01/1991
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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