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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 K023805
Device Name LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
Applicant
Laerdal Medical A/S
Tanke Svilandsgate 30
Stavanger,  NO 4002
Applicant Contact MAGNE STEINSET
Correspondent
Laerdal Medical A/S
Tanke Svilandsgate 30
Stavanger,  NO 4002
Correspondent Contact MAGNE STEINSET
Regulation Number868.5870
Classification Product Code
CBP  
Date Received11/14/2002
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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