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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K173437
Device Name 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Applicant Contact Hilary B. Hovde
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Pauk,  MN  55144
Correspondent Contact Hilary B. Hovde
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/03/2017
Decision Date 03/19/2018
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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