FDA 510(k) Application Details - K121920

Device Classification Name Laser, Comb, Hair

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510(K) Number K121920
Device Name Laser, Comb, Hair
Applicant SUNETICS INTERNATIONAL MARKETING GROUP, LLC
892 STEGER TOWNE RD #44
ROCKWALL, TX 75032 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 07/02/2012
Decision Date 06/27/2013
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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