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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valve, non-rebreathing
510(k) Number K081516
Device Name MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
Applicant
MEDSOURCE INTERNATIONAL, LLC.
5346 SHORELINE DR.
MOUND,  MN  55364
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/30/2008
Decision Date 08/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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