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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K913316
Device Name DEVILBISS MODEL 7427D
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact TERRENCE M O'BRIEN
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact TERRENCE M O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/24/1991
Decision Date 12/11/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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