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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 K844852
Device Name THE GENERIC OXYGEN CONCENTRATOR
Applicant
PROTO-MED, INC.
5360 MANHATTAN CIRCLE
BOULDER,  CO  80303
Applicant Contact JOHN A SICHEL
Correspondent
PROTO-MED, INC.
5360 MANHATTAN CIRCLE
BOULDER,  CO  80303
Correspondent Contact JOHN A SICHEL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/13/1984
Decision Date 12/27/1984
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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