FDA 510(k) Application Details - K132307

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K132307
Device Name Light, Surgical, Ceiling Mounted
Applicant CONVIDA HEALTHCARE & SYSTEMS CORPORATION
2F AND B2, NO.33, DINGHU RD
GUISHAN TOWNSHIP
TAOYUAN COUNTY 33378 TW
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Contact RYAN HUNG
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 07/24/2013
Decision Date 11/05/2013
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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