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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 K110053
Device Name CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
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 Received01/07/2011
Decision Date 09/14/2012
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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