FDA 510(k) Application Details - K210367

Device Classification Name Laser, Dental, Soft Tissue

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510(K) Number K210367
Device Name Laser, Dental, Soft Tissue
Applicant Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park, Guilin National High-Tech Zone
Guilin 541004 CN
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Contact Yang Yunfeng
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Regulation Number 878.4810

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Classification Product Code NVK
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Date Received 02/08/2021
Decision Date 03/10/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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