FDA 510(k) Application Details - K210135

Device Classification Name Dressing, Wound, Drug

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510(K) Number K210135
Device Name Dressing, Wound, Drug
Applicant 3M Health Care Business Group
3M Centre, Cain Road
Berkshire, Bracknell Forest RG12 8HT, GB
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Contact Margaret Marsh
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 01/19/2021
Decision Date 02/24/2022
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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