FDA 510(k) Application Details - K022807

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K022807
Device Name Powered Laser Surgical Instrument
Applicant CREATIVE TECHNOLOGIES, INC.
423 BETHEL DR.
SALISBURY, NC 28144 US
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Contact ELIZABETH P NOBLE
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 08/23/2002
Decision Date 01/29/2003
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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