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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K141152
Device Name ADVANTAGE
Applicant
STEVENSON INDUSTRIES, INC.
780 CHAMBERS LANE SUITE 200
SIMI VALLEY,  CA  93065
Applicant Contact SERRAH NAMINI
Correspondent
STEVENSON INDUSTRIES, INC.
780 CHAMBERS LANE SUITE 200
SIMI VALLEY,  CA  93065
Correspondent Contact SERRAH NAMINI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/05/2014
Decision Date 10/17/2014
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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