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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, Powered (Resuscitator)
510(k) Number K093261
Device Name MOVES
Applicant
Thornhill Research, Inc.
70 Peter St. 2nd Floor
Toronto, Ontario,  CA M5V 2G5
Applicant Contact CLIFF ANSEL
Correspondent
Thornhill Research, Inc.
70 Peter St. 2nd Floor
Toronto, Ontario,  CA M5V 2G5
Correspondent Contact CLIFF ANSEL
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/19/2009
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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