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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 K965027
Device Name VENTED I.V. SET
Original Applicant
hiroshima, 730,  JP
Original Contact tetsukara hirose
Regulation Number880.5440
Classification Product Code
Date Received12/17/1996
Decision Date 06/24/1997
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