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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 Health Care
2510 Conway Avenue, Bldg. 275-5W-06
St. Paul,  MN  55144 -1000
Applicant Contact Andrew Wingen
Correspondent
3M Health Care
2510 Conway Avenue, Bldg. 275-5W-06
St. 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
Recalls CDRH Recalls
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