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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K844313
Device Name INFUSET W/HUBER NEEDLE
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 Number880.5570
Classification Product Code
FMI  
Date Received11/06/1984
Decision Date 01/22/1985
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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