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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 K882302
Device Name IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
Applicant
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Applicant Contact KIMBERLY M CARLSON
Correspondent
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Correspondent Contact KIMBERLY M CARLSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/02/1988
Decision Date 07/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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