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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K040260
Device Name INTEGRAL HEMODIALYSIS CATHETER
Applicant
Arrow Int'L.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact BRANDON EPTING
Correspondent
Arrow Int'L.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact BRANDON EPTING
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/04/2004
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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