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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 K971129
Device Name OXYPURE PORTABLE OXYGEN GENERATOR
Applicant
Arbor Research Corp.
806 Airport Blvd.
Ann Arbor,  MI  48108
Applicant Contact BLAKE M PATERSON
Correspondent
Arbor Research Corp.
806 Airport Blvd.
Ann Arbor,  MI  48108
Correspondent Contact BLAKE M PATERSON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/27/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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