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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K021328
Device Name SMART BAG MO
Applicant
O-TWO SYSTEMS INTERNATIONAL INC.
7575 KIMBEL ST.
MISSISSAUGA,ONTARIO,  CA L5S 1C8
Applicant Contact KEVIN BOWDEN
Correspondent
O-TWO SYSTEMS INTERNATIONAL INC.
7575 KIMBEL ST.
MISSISSAUGA,ONTARIO,  CA L5S 1C8
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/26/2002
Decision Date 06/26/2003
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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