FDA 510(k) Application Details - K020513

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K020513
Device Name Powered Laser Surgical Instrument
Applicant DDC TECHNOLOGIES, INC.
2980 WAVERLY AVE.
OCEANSIDE, NY 11572 US
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Contact DMITRY DONSKOY
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 02/15/2002
Decision Date 05/16/2002
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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