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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K940127
Device Name CENTERMARK SECURING WINGS
Applicant
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Applicant Contact THOM LAWSON
Correspondent
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Correspondent Contact THOM LAWSON
Regulation Number880.5210
Classification Product Code
KMK  
Date Received01/10/1994
Decision Date 02/09/1994
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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