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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K890095
Device Name PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET
Applicant
Kells Medical, Inc.
1518 - Conestoga Ct.
Redlands,  CA  92373
Applicant Contact CHARLES M GREY
Correspondent
Kells Medical, Inc.
1518 - Conestoga Ct.
Redlands,  CA  92373
Correspondent Contact CHARLES M GREY
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/10/1989
Decision Date 05/24/1989
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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