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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 K991722
Device Name DEVILBISS 5 LITER OXYGEN CONCENTRATOR
Applicant
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact GREG CLITES
Correspondent
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact GREG CLITES
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/20/1999
Decision Date 11/03/1999
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
Recalls CDRH Recalls
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