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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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