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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 K925502
Device Name TRACE MODEL# 840, 841,842 & 845 ARM BOARD
Applicant
Trace Medical Equipment, Inc.
5000 Varsity Dr.
Lisle,  IL  60532
Applicant Contact JOHN G NOVACK
Correspondent
Trace Medical Equipment, Inc.
5000 Varsity Dr.
Lisle,  IL  60532
Correspondent Contact JOHN G NOVACK
Regulation Number880.5210
Classification Product Code
KMK  
Date Received10/30/1992
Decision Date 01/12/1993
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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