FDA 510(k) Application Details - K090378

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K090378
Device Name Light, Surgical, Ceiling Mounted
Applicant BERCHTOLD GMBH & CO. KG
1950 HANAHAN ROAD
CHARLESTON, SC 29406 US
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Contact HEATH HINES
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 02/17/2009
Decision Date 02/23/2009
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

FDA Source Information for K090378


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