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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 K101154
Device Name CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
Applicant
AIRSEP CORP.
401 CREEKSIDE DR.
BUFFALO,  NY  14228 -2085
Applicant Contact PETER WEISENBORN
Correspondent
AIRSEP CORP.
401 CREEKSIDE DR.
BUFFALO,  NY  14228 -2085
Correspondent Contact PETER WEISENBORN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/23/2010
Decision Date 03/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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