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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 K020932
Device Name DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
Applicant
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact RAY HOFFMAN
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
BTI  
Date Received03/22/2002
Decision Date 06/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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