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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 K760880
Device Name ADDITIVE CAP (2B8905)
Applicant
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5025
Classification Product Code
KPE  
Date Received10/21/1976
Decision Date 12/30/1976
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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