FDA 510(k) Application Details - K242183

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K242183
Device Name Powered Laser Surgical Instrument
Applicant Weifang Mingliang Electronics CO., LTD.
1-301, Building 15, Phase 1, Yuandu Huizhi IndustrialComplex
No.3999, Taixiang Street, Weifang Economic Development Zone
Weifang 261000 CN
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Contact Lv Alisa
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/25/2024
Decision Date 10/23/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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 K242183


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