FDA 510(k) Application Details - K122875

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K122875
Device Name Light, Surgical, Ceiling Mounted
Applicant ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN, PA 18951 US
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Contact DAVID T JAMISON
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 09/19/2012
Decision Date 12/18/2012
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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