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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
Med Fusion Systems, Inc.
1250 Powers Ferry Rd.
Marietta,  GA  30067
Applicant Contact WILLIAM D ARTHUR
Correspondent
Med Fusion 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
Predetermined Change
Control Plan Authorized		 No
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