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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K261992
Device Name 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
Applicant
Solventum US, LLC
12930 Ih 10 W.
San Antonio,  TX  78249
Applicant Contact Heidi Wallis
Correspondent
Solventum US, LLC
12930 Ih 10 W.
San Antonio,  TX  78249
Correspondent Contact Heidi Wallis
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/15/2026
Decision Date 09/25/2026
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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