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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 K942021
Device Name MOUTH TO MOUTH BREATHER
Applicant
Gam Industries, Inc.
P.O. Box 2226
Petersburg,  VA  23804
Applicant Contact GARY BEDEN
Correspondent
Gam Industries, Inc.
P.O. Box 2226
Petersburg,  VA  23804
Correspondent Contact GARY BEDEN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received04/26/1994
Decision Date 06/22/1994
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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