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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 K971293
Device Name LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
Applicant
ABBOTT MFG., INC.
TWO HUNDRED S. ABBOTT PRK. RD.
D 389, BLDG AP 30
ABBOTT PARK,  IL  60064 -3500
Applicant Contact THOMAS P SAMPOGNA
Correspondent
ABBOTT MFG., INC.
TWO HUNDRED S. ABBOTT PRK. RD.
D 389, BLDG AP 30
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact THOMAS P SAMPOGNA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/07/1997
Decision Date 06/27/1997
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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