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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 K073451
Device Name PRESSURE INJECTABLE PICC
Applicant
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact KEVIN LENTZ
Correspondent
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact KEVIN LENTZ
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/10/2007
Decision Date 01/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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