FDA 510(k) Application Details - K032218

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K032218
Device Name Powered Laser Surgical Instrument
Applicant ADEPT MEDICAL CONCEPTS
29816 AVENIDA DE LAS BANDERAS
RANCHO SANTA MARGARITA, CA 92688 US
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Contact JERRY MCFARLAND
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/21/2003
Decision Date 10/24/2003
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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