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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K842984
Device Name EXTENSION SET W/INJECTION SITE
Applicant
MEDFUSION SYSTEMS, INC.
1250 POWERS FERRY RD.
MARIETTA,  GA  30067
Applicant Contact WILLIAM D ARTHUR
Correspondent
MEDFUSION SYSTEMS, INC.
1250 POWERS FERRY RD.
MARIETTA,  GA  30067
Correspondent Contact WILLIAM D ARTHUR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/30/1984
Decision Date 10/16/1984
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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