FDA 510(k) Application Details - K220673

Device Classification Name Dressing, Wound, Drug

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510(K) Number K220673
Device Name Dressing, Wound, Drug
Applicant Qingdao Bright Moon Biomedical Materials Co., Ltd.
No. 788, Bright Moon Road, Huangdao District
Qingdao 266400 CN
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Contact Deng Yunlong
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 03/07/2022
Decision Date 03/16/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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