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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 K943386
Device Name CPR MICROMASK
Applicant
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031
Applicant Contact GARY S BOTSFORD
Correspondent
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031
Correspondent Contact GARY S BOTSFORD
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/13/1994
Decision Date 02/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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