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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 K861401
Device Name LAERDAL POCKET MASK
Applicant
Laerdal Medical Corp.
P.O. Box 190, One Labriola Ct.
Armonk,  NY  10504
Applicant Contact RONALD L WEYHRAUCH
Correspondent
Laerdal Medical Corp.
P.O. Box 190, One Labriola Ct.
Armonk,  NY  10504
Correspondent Contact RONALD L WEYHRAUCH
Regulation Number868.5870
Classification Product Code
CBP  
Date Received04/15/1986
Decision Date 05/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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