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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, fistula
510(k) Number K832136
Device Name DUAL FLOW NEEDLE
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 Number876.5540
Classification Product Code
FIE  
Date Received07/01/1983
Decision Date 10/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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