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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K081468
Device Name DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
Applicant
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/27/2008
Decision Date 08/25/2008
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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