FDA 510(k) Application Details - K023081

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K023081
Device Name Powered Laser Surgical Instrument
Applicant MEDICAL BIO CARE SWEDEN AB
908 STETSON ST.
WOODLAND, CA 95776 US
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Contact CONNIE WHITE HOY
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 09/17/2002
Decision Date 12/16/2002
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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