FDA 510(k) Application Details - K240340

Device Classification Name Drill, Bone, Powered

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510(K) Number K240340
Device Name Drill, Bone, Powered
Applicant Guangdong Jinme Medical Technology Co., Ltd.
Room 301, 401, 501, Block No.3, Wanyang Science Park, 84
Taoyuan East Rd. Shishan Town, Nanhai District
Foshan 528200 CN
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Contact Ying Yang
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 02/05/2024
Decision Date 07/18/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240340


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