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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 K052743
Device Name DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
Applicant
DYNAREX CORP.
10 GLENSHAW ST.
ORANGEBURG,  NY  10962
Applicant Contact JAMES HURLMAN
Correspondent
DYNAREX CORP.
10 GLENSHAW ST.
ORANGEBURG,  NY  10962
Correspondent Contact JAMES HURLMAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/30/2005
Decision Date 12/22/2005
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
Recalls CDRH Recalls
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