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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, Short-Term Less Than 30 Days
510(k) Number K993691
Device Name ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/01/1999
Decision Date 03/08/2000
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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