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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 K863814
Device Name BAG SPIKE EXTENSION SET
Applicant
MEDFUSION SYSTEMS, INC.
3070 BUSINESS PARK DR.
NORCROSS,  GA  30071
Applicant Contact RUFFIN BOOTH
Correspondent
MEDFUSION SYSTEMS, INC.
3070 BUSINESS PARK DR.
NORCROSS,  GA  30071
Correspondent Contact RUFFIN BOOTH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/30/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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