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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 K844080
Device Name ARROW-GEISS PERCUTANEOUS TPN KIT
Applicant
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Applicant Contact RONALD P CITRON
Correspondent
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Correspondent Contact RONALD P CITRON
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/19/1984
Decision Date 04/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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