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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 K984569
Device Name AB2 MED-FLO SOLUTION SET
Applicant
AB2 MEDICAL PRODUCTS, LLP
52 BUTTONBUSH CT.
THE WOODLANDS,  TX  77380 -0926
Applicant Contact ARTHUR CHANDLER,III
Correspondent
AB2 MEDICAL PRODUCTS, LLP
52 BUTTONBUSH CT.
THE WOODLANDS,  TX  77380 -0926
Correspondent Contact ARTHUR CHANDLER,III
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/23/1998
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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