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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 K101528
Device Name 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
Applicant
3M COMPANY
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55144 -1000
Applicant Contact SUZANNE LEUNG
Correspondent
3M COMPANY
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55144 -1000
Correspondent Contact SUZANNE LEUNG
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/02/2010
Decision Date 10/01/2010
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
Recalls CDRH Recalls
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