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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,long-term greater than 30 days
510(k) Number K121501
Device Name ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
Original Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 bernville rd.
reading,  PA  19605
Original Contact julie lawson
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/21/2012
Decision Date 11/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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