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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 K781300
Device Name OXYGEN CONCENTRATOR
Applicant
BENDIX INSTRUMENTS & LIFE SUPPORT DIV
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BENDIX INSTRUMENTS & LIFE SUPPORT DIV
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/28/1978
Decision Date 10/16/1978
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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