FDA 510(k) Application Details - K011693

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K011693
Device Name Light, Surgical, Ceiling Mounted
Applicant TRUMPF MEDICAL SYSTEMS, INC.
415 JESSEN LN.
WANDO, SC 29492 US
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Contact WILLIAM APPERSON
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 05/31/2001
Decision Date 06/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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