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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name A Chemical Vapor Sterilization Multivariable Chemical Indicator
510(k) Number K193110
Device Name 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Applicant
3M Healthcare
2510 Conway Ave., Bldg. 275-5w-06
Saint Paul,  MN  55144 -1000
Applicant Contact Andrew Wingen
Correspondent
3M Healthcare
2510 Conway Ave., Bldg. 275-5w-06
Saint Paul,  MN  55144 -1000
Correspondent Contact Andrew Wingen
Regulation Number880.2800
Classification Product Code
QKM  
Date Received11/12/2019
Decision Date 03/13/2020
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
Recalls CDRH Recalls
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