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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K860803
Device Name IV FILTER EXTENSION SET
Applicant
Med Fusion Systems, Inc.
3070 Business Park Dr.
Norcross,  GA  30071
Applicant Contact WILLIAM D ARTHUR
Correspondent
Med Fusion Systems, Inc.
3070 Business Park Dr.
Norcross,  GA  30071
Correspondent Contact WILLIAM D ARTHUR
Regulation Number880.5440
Classification Product Code
FPB  
Date Received03/04/1986
Decision Date 04/09/1986
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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