FDA 510(k) Application Details - K021946

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K021946
Device Name Powered Laser Surgical Instrument
Applicant CELL ROBOTICS, INC.
2715 BROADBENT PKWY., N.E.
ALBUQUERQUE, NM 87107 US
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Contact GLEN GOFF
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 06/13/2002
Decision Date 09/11/2002
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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