FDA 510(k) Application Details - K093499

Device Classification Name Laser, Comb, Hair

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510(K) Number K093499
Device Name Laser, Comb, Hair
Applicant LEXINGTON INTERNATIONAL, LLC
901 KING STREET, SUITE 200
ALEXANDRIA, VA 22314 US
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Contact CHERITA JAMES
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 11/12/2009
Decision Date 11/23/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
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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