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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, Short-Term Less Than 30 Days
510(k) Number K901640
Device Name MULTICATH PLACEMENT KIT
Applicant
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/09/1990
Decision Date 08/10/1990
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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