FDA 510(k) Application Details - K221110

Device Classification Name Dressing, Wound, Drug

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510(K) Number K221110
Device Name Dressing, Wound, Drug
Applicant Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd, Dongjiang Hi-tech Industrial Park
Huizhou 516005 CN
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Contact Jie Dong
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 04/15/2022
Decision Date 01/04/2024
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

FDA Source Information for K221110


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