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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 K790520
Device Name AIRCARE OXYGEN GENERATOR
Applicant
Medical Services of America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Services of America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/16/1979
Decision Date 04/18/1979
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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