FDA 510(k) Application Details - K983673

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K983673
Device Name Powered Laser Surgical Instrument
Applicant CELL ROBOTICS, INC.
2715 BROADBENT PKWY., N.E.
ALBUQUERQUE, NM 87107 US
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Contact RONALD K LOHRDING
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 10/20/1998
Decision Date 01/15/1999
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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