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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K140264
Device Name MADM
Applicant
THORNHILL RESEARCH INC.
210 Dundas St. West
Suite 200
TORONTO, ONTARIO,  CA M5G 2E8
Applicant Contact CLIFF ANSEL
Correspondent
THORNHILL RESEARCH INC.
210 Dundas St. West
Suite 200
TORONTO, ONTARIO,  CA M5G 2E8
Correspondent Contact CLIFF ANSEL
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received02/03/2014
Decision Date 01/05/2015
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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