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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K900415
Device Name C.P.R. LANDMARC
Applicant
Can-Am Medical, Inc.
21 Ross St., Dryden
Ontario P8n 1t8,  CA
Applicant Contact CARLA K HANSON
Correspondent
Can-Am Medical, Inc.
21 Ross St., Dryden
Ontario P8n 1t8,  CA
Correspondent Contact CARLA K HANSON
Regulation Number870.5210
Classification Product Code
LIX  
Date Received01/30/1990
Decision Date 06/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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