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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 K844255
Device Name GENT-L-KARE STERILE I.V. START KIT
Applicant
Geneva Laboratories, Inc.
P.O. Box 444
Elkhorn,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
Geneva Laboratories, Inc.
P.O. Box 444
Elkhorn,  WI  53121
Correspondent Contact GARY L SWANSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/02/1984
Decision Date 12/19/1984
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
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