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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 K960280
Device Name IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
Applicant
Y
10300 CAMPUS POINT DR.
SAN DIEGO,  CA  92121 -1579
Applicant Contact JENNIFER S HANKARD
Correspondent
Y
10300 CAMPUS POINT DR.
SAN DIEGO,  CA  92121 -1579
Correspondent Contact JENNIFER S HANKARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/19/1996
Decision Date 04/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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