FDA 510(k) Application Details - K222859

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K222859
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant 3M
6203 Farinon Drive
San Antonio, TX 78249 US
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Contact Melanie Avila
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 09/22/2022
Decision Date 03/23/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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