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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 K183209
Device Name 3M Comply Hydrogen Peroxide Indicator Tape
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact Nadia Battah
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact Nadia Battah
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received11/19/2018
Decision Date 02/15/2019
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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