FDA 510(k) Application Details - K925145

Device Classification Name Splint, Extremity, Noninflatable, External, Sterile

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510(K) Number K925145
Device Name Splint, Extremity, Noninflatable, External, Sterile
Applicant TRACE MEDICAL EQUIPMENT, INC.
5000 VARSITY DR.
LISLE, IL US
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Contact JOHN NOVACK
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Regulation Number 878.3910

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Classification Product Code FYH
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Date Received 10/13/1992
Decision Date 05/19/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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