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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 Ave.S
Reading,  PA  19610
Applicant Contact RONALD P CITRON
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.S
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
Predetermined Change
Control Plan Authorized		 No
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