FDA 510(k) Application Details - K000639

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K000639
Device Name Light, Surgical, Ceiling Mounted
Applicant BURTON MEDICAL PRODUCTS CORP.
21100 LASSEN ST.
CHATSWORTH, CA 91311 US
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Contact DORIAN SWARTZ
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 02/25/2000
Decision Date 05/25/2000
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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