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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 K861435
Device Name BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE
Applicant
The John Bunn Co.
290 Creekside Dr.
Tonawanda,  NY  14150
Applicant Contact DENNIS KENYON
Correspondent
The John Bunn Co.
290 Creekside Dr.
Tonawanda,  NY  14150
Correspondent Contact DENNIS KENYON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/17/1986
Decision Date 11/07/1986
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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