FDA 510(k) Application Details - K222578

Device Classification Name Drape, Surgical

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510(K) Number K222578
Device Name Drape, Surgical
Applicant 3M Company
2510 Conway Ave.
Building 275-5W-06
St. Paul, MN 55144 US
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Contact Hilary Hovde
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 08/25/2022
Decision Date 05/18/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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