FDA 510(k) Application Details - K173846

Device Classification Name Laser, Comb, Hair

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510(K) Number K173846
Device Name Laser, Comb, Hair
Applicant DermaScalp LLC
190 E. Stacy Rd
Suite 306-291
Allen, TX 75002 US
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Contact John Carullo
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 12/19/2017
Decision Date 03/21/2018
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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