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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 K920128
Device Name VERSACATH MAINLINE CENTRAL VENOUS CATHETER
Applicant
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Applicant Contact JOCK M WALKER
Correspondent
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Correspondent Contact JOCK M WALKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/13/1992
Decision Date 03/26/1992
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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