FDA 510(k) Application Details - K965130

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K965130
Device Name Light, Surgical, Ceiling Mounted
Applicant BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN D-78532 DE
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Contact W. HILL
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 12/23/1996
Decision Date 07/14/1997
Decision SESE - SUBST EQUIV
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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