FDA 510(k) Application Details - K071451

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K071451
Device Name Powered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH
1A; IM SEMMICHT
JENA 07751 DE
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Contact ANTJE KATZER
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 05/24/2007
Decision Date 08/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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