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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 K894384
Device Name K.E.E. OXYGEN CONCENTRATOR
Applicant
Kee Medical Services, Inc.
8 Belvedere Dr.
Mechanicsburg,  PA  17055
Applicant Contact STEPHEN M GREEN
Correspondent
Kee Medical Services, Inc.
8 Belvedere Dr.
Mechanicsburg,  PA  17055
Correspondent Contact STEPHEN M GREEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/17/1989
Decision Date 10/27/1989
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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