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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 K222508
Device Name 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
Applicant
3M Company
2510 Conway Avenue, Bldg. 275-5W-06
St. Paul,  MN  55144 -1000
Applicant Contact Yumi Wackerfuss
Correspondent
3M Company
3M Center, Bldg. 275-5W-06
St. Paul,  MN  55144 -1000
Correspondent Contact Yumi Wackerfuss
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/18/2022
Decision Date 11/01/2022
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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