FDA 510(k) Application Details - K223310

Device Classification Name Dressing, Wound, Drug

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510(K) Number K223310
Device Name Dressing, Wound, Drug
Applicant Advanced Medical Solutions Limited
Premier Park, 33 Road One
Winsford Industrial Estate
Winsford CW7 3RT GB
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Contact Kay Mcgrath
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/28/2022
Decision Date 04/05/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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