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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name indicator, biological sterilization process
510(k) Number K200766
Device Name 3M Attest Steam Chemical Integrator Test Pack
Applicant
3M Company
3M Center, Building 275-5W-06
st. paul,  MN  55144
Applicant Contact mary fretland
Correspondent
3M Company
3M Center, Building 275-5W-06
st. paul,  MN  55144
Correspondent Contact mary fretland
Regulation Number880.2800
Classification Product Code
FRC  
Subsequent Product Code
JOJ  
Date Received03/25/2020
Decision Date 07/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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