FDA 510(k) Application Details - K203284

Device Classification Name

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510(K) Number K203284
Device Name 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
Applicant 3M Company
2510 Conway Ave, Bldg 275-5W-06
St. Paul, MN 55144-1000 US
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Contact Andrew Wingen
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Regulation Number

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Classification Product Code QKM
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Date Received 11/09/2020
Decision Date 12/07/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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