FDA 510(k) Application Details - K103368

Device Classification Name Laser, Comb, Hair

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510(K) Number K103368
Device Name Laser, Comb, Hair
Applicant LEXINGTON INTERNATIONAL, LLC
1400 SIXTEENTH STREET, NW
SUITE 400
WASHINGTON, DC 20036 US
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Contact CASPER E ULDRIKS ESQ.
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 11/17/2010
Decision Date 04/06/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
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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