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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 K945521
Device Name CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
Applicant
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Applicant Contact THOM LAWSON
Correspondent
Menlo Care, Inc.
1350 Willow Rd.
Menlo Park,  CA  94025
Correspondent Contact THOM LAWSON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/10/1994
Decision Date 04/06/1995
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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