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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 K203458
Device Name 3M Comply Hydrogen Peroxide Chemical Indicator 1248
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Applicant Contact Yumi Wackerfuss
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Correspondent Contact Yumi Wackerfuss
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received11/24/2020
Decision Date 12/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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