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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 K020324
Device Name LIFESTYLE OXYGEN CONCENTRATOR
Applicant
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Applicant Contact CHARLOTTE H HAMILTON
Correspondent
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Correspondent Contact CHARLOTTE H HAMILTON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/31/2002
Decision Date 03/13/2002
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
Recalls CDRH Recalls
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