FDA 510(k) Application Details - K223495

Device Classification Name Dressing, Wound, Drug

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510(K) Number K223495
Device Name Dressing, Wound, Drug
Applicant Hangzhou Zeo-Innov Life Technology Co., Ltd
101, Building 2, No.291 Fucheng Road
Hangzhou 310018 CN
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Contact Zhao Lijuan
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 11/21/2022
Decision Date 05/02/2023
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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