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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 K150930
Device Name Deployable Oxygen Generation System-Smaill (DOGS-S)
Applicant
Airsep Corporation
260 Creekside Dr.
Buffalo,  NY  14228
Applicant Contact Peter Weisenborn
Correspondent
Airsep Corporation
260 Creekside Dr.
Buffalo,  NY  14228
Correspondent Contact Ted Vlahopoulos
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/06/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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