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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 K243501
Device Name 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
Applicant
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact Michelle Larsen
Correspondent
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact Michelle Larsen
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/12/2024
Decision Date 01/28/2025
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
Predetermined Change
Control Plan Authorized		 No
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