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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K871908
Device Name IV ADMINISTRATION SET
Applicant
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Applicant Contact DENNIS OCWIEJA
Correspondent
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Correspondent Contact DENNIS OCWIEJA
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received05/15/1987
Decision Date 07/27/1987
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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