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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 K122027
Model FB-19604-K, FB-19605-SNS
Device Name ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
Original Applicant
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading,  PA  19605
Original Contact paul amudala
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/11/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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