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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 K944660
Device Name ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY
Applicant
NEOSTAR MEDICAL TECHNOLOGIES, INC.
100 ROSS RD.
KING OF PRUSSIA,  PA  19406
Applicant Contact TROY M HARMON
Correspondent
NEOSTAR MEDICAL TECHNOLOGIES, INC.
100 ROSS RD.
KING OF PRUSSIA,  PA  19406
Correspondent Contact TROY M HARMON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/21/1994
Decision Date 03/13/1995
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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