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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 K212081
Device Name 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Applicant Contact Mary Fretland
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Correspondent Contact Mary Fretland
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/02/2021
Decision Date 09/05/2021
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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