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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 K200092
Device Name 3MTM AttestTM Mini Auto-reader 490M
Applicant
3M
2510 Conway Ave, Bldg 275-5W-06
st. paul,  MN  55144 -1000
Applicant Contact andrew wingen
Correspondent
3M
2510 Conway Ave, Bldg 275-5W-06
st. paul,  MN  55144 -1000
Correspondent Contact andrew wingen
Regulation Number880.2800
Classification Product Code
FRC  
Date Received01/16/2020
Decision Date 04/15/2020
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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