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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K992424
Device Name SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
Applicant
Plastimed Laboratoire Pharmaceutique
95321 Saint-Lue-La-Foret
Cedex,  FR
Applicant Contact JEAN-DANIEL NURY
Correspondent
Plastimed Laboratoire Pharmaceutique
95321 Saint-Lue-La-Foret
Cedex,  FR
Correspondent Contact JEAN-DANIEL NURY
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/21/1999
Decision Date 12/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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