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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K962766
Device Name AIRSEP IMPULSE
Applicant
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Applicant Contact MARK MIZERKIEWICZ
Correspondent
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Correspondent Contact MARK MIZERKIEWICZ
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/16/1996
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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