FDA 510(k) Application Details - K970886

Device Classification Name Light, Surgical, Floor Standing

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510(K) Number K970886
Device Name Light, Surgical, Floor Standing
Applicant HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU D-63450 DE
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Contact MARK SCHULZ
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Regulation Number 878.4580

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Classification Product Code FSS
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Date Received 02/06/1997
Decision Date 04/16/1997
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 N
Expedited Review



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