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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Non-Rebreathing
510(k) Number K933048
Device Name LAERDAL(TM) POCKET MASK, MODIFICATION
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 Number868.5570
Classification Product Code
KGB  
Date Received05/11/1993
Decision Date 12/02/1993
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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