FDA 510(k) Application Details - K222657

Device Classification Name Dressing, Wound, Drug

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510(K) Number K222657
Device Name Dressing, Wound, Drug
Applicant MEBO Life Science Inc.
325 North Puente Street # A
Brea, CA 92821 US
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Contact Sidney Hong
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 09/02/2022
Decision Date 10/18/2022
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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