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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stopcock, i.v. set
510(k) Number K830198
Device Name PEDIATRIC EXTEN. SET FOR SECOND-DRUG
Applicant
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FMG  
Date Received01/20/1983
Decision Date 02/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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