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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 K121403
Device Name CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
Original Applicant
TELEFLEX, INC.
2400 bernville road
reading,  PA  19605
Original Contact paul amudala
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/21/2012
Decision Date 06/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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