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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 K850346
Device Name OXYGEN CONCENTRATOR
Applicant
Inspiron Corp.
8600 Archibald Ave.
Rancho Cucamonga,  CA  91730
Applicant Contact THOMAS C BREWSTER
Correspondent
Inspiron Corp.
8600 Archibald Ave.
Rancho Cucamonga,  CA  91730
Correspondent Contact THOMAS C BREWSTER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/28/1985
Decision Date 02/04/1985
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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