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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K092657
Device Name EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact CINDY ENGELHARDT
Correspondent
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact CINDY ENGELHARDT
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/28/2009
Decision Date 11/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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