FDA 510(k) Application Details - K014236

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K014236
Device Name Powered Laser Surgical Instrument
Applicant CLINICON CORP.
16787 BERNARDO CENTER DR.
SUITE A
SAN DIEGO, CA 92128 US
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Contact SEAN M CURRY
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 12/26/2001
Decision Date 03/26/2002
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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