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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, nebulizer, manual
510(k) Number K896090
Device Name DEVILBISS MODEL 6300D
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact S MOSHOLDER
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact S MOSHOLDER
Regulation Number874.5220
Classification Product Code
EPN  
Date Received10/19/1989
Decision Date 11/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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