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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 K852209
Device Name DEVO/MC29 OXYGEN CONCENTRATOR MC29D
Applicant
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Applicant Contact JAMES C STANGE
Correspondent
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Correspondent Contact JAMES C STANGE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/21/1985
Decision Date 06/24/1985
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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