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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 K884581
Device Name RELIANT OXYGEN CONCENTRATOR
Applicant
AIRSEP CORP.
84 AERO DR.
BUFFALO,  NY  14225
Applicant Contact PETER WEISENBORN
Correspondent
AIRSEP CORP.
84 AERO DR.
BUFFALO,  NY  14225
Correspondent Contact PETER WEISENBORN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/02/1988
Decision Date 01/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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