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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 K872470
Device Name DEVO/MC44 OXYGEN CONCENTRATOR
Applicant
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Applicant Contact TERRENCE M O'BRIEN
Correspondent
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Correspondent Contact TERRENCE M O'BRIEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/08/1987
Decision Date 08/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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