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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 K893388
Device Name DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact DAVID GAST
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact DAVID GAST
Regulation Number868.5965
Classification Product Code
BYE  
Date Received05/01/1989
Decision Date 06/23/1989
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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