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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)
Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact JULIE LAWSON
Correspondent
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent 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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