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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 K980052
Device Name RESPAIDE
Applicant
EMERGENCY FILTRATION PRODUCTS, INC.
321 NORTH MALL DR.
SUITE H103
ST. GEORGE,  UT  84790
Applicant Contact MICHAEL J CRNKOVICH
Correspondent
EMERGENCY FILTRATION PRODUCTS, INC.
321 NORTH MALL DR.
SUITE H103
ST. GEORGE,  UT  84790
Correspondent Contact MICHAEL J CRNKOVICH
Regulation Number868.5870
Classification Product Code
CBP  
Date Received01/06/1998
Decision Date 08/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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