FDA 510(k) Application Details - K240689

Device Classification Name Laser, Comb, Hair

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510(K) Number K240689
Device Name Laser, Comb, Hair
Applicant Telebrands Corporation
One Telebrands Plaza
Fairfield, NJ 07004 US
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Contact Shepard Bentley
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 03/13/2024
Decision Date 09/17/2024
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 K240689


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