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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 K860060
Device Name RX02 PLUS OXYGEN CONCENTRATOR
Applicant
THE JOHN BUNN CO.
290 CREEKSIDE DR.
TONAWANDA,  NY  14150
Applicant Contact PETER WEISENBORN
Correspondent
THE JOHN BUNN CO.
290 CREEKSIDE DR.
TONAWANDA,  NY  14150
Correspondent Contact PETER WEISENBORN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/06/1986
Decision Date 02/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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