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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 K993492
Device Name DEVILBISS NEBULIZER MODEL 800
Applicant
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact FRANK CLEMENTI
Correspondent
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact FRANK CLEMENTI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/15/1999
Decision Date 04/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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