FDA 510(k) Application Details - K173843

Device Classification Name Laser, Comb, Hair

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510(K) Number K173843
Device Name Laser, Comb, Hair
Applicant EGlobal, LLC
10115 E Bell Rd
Suite 107
Scottsdale, AZ 85260 US
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Contact Wayne De Stefano
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 12/18/2017
Decision Date 01/26/2018
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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