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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
Recalls CDRH Recalls
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