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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 K951620
Device Name MIDMARK MIDLINE CATHETER
Applicant
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Applicant Contact THOMAS LAWSON
Correspondent
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Correspondent Contact THOMAS LAWSON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/07/1995
Decision Date 04/04/1996
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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