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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 K101910
Device Name 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact SUZANNE LEUNG
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact SUZANNE LEUNG
Regulation Number880.2800
Classification Product Code
FRC  
Subsequent Product Code
JOJ  
Date Received07/09/2010
Decision Date 12/08/2010
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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