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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 K872534
Device Name 4LYF 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 Received06/26/1987
Decision Date 10/13/1987
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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