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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Noninflatable, External, Sterile
510(k) Number K925145
Device Name TRACE MODEL #'S 840, 841, 842, 845
Applicant
Trace Medical Equipment, Inc.
5000 Varsity Dr.
Lisle,  IL  60532
Applicant Contact JOHN NOVACK
Correspondent
Trace Medical Equipment, Inc.
5000 Varsity Dr.
Lisle,  IL  60532
Correspondent Contact JOHN NOVACK
Regulation Number878.3910
Classification Product Code
FYH  
Date Received10/13/1992
Decision Date 05/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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