FDA 510(k) Application Details - K193667

Device Classification Name Laser, Comb, Hair

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510(K) Number K193667
Device Name Laser, Comb, Hair
Applicant Conversion Labs, PR, LLC
53 Calle Las Palmeras, Suite 802
San Juan, PR 00901 US
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Contact Stefan Galluppi
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 12/31/2019
Decision Date 03/25/2020
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

FDA Source Information for K193667


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