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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 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Applicant Contact S MOSHOLDER
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
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
Predetermined Change
Control Plan Authorized		 No
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