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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 K900263
Device Name ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/18/1990
Decision Date 07/24/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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